Wednesday, July 23, 2014

What are the top three benefits of cloud computing for clinical trials?

We recently had a chance to sit down with Partnerships in Medical Device Clinical Trials partner company Clinovo to discuss some of the benefits of cloud computing for clinical trials.  Over the next few weeks, we'll examine our interview with Marc Desgrousilliers, the Chief Technology Officer of Clinovo.

Today, he answers the question:
In your opinion, what are the top three benefits of cloud computing for clinical trials?

Marc: The first one is self-service which is essentially the removal of IT dependency. IT can sometimes be slow to respond to new business requirements seeing that they spend 70% of their budget in maintaining current systems and applications. In addition, contracting professional IT services is very expensive. In the Cloud, clinical trial professionals are able to run their own studies without any IT intervention, nor high upfront investment. They are completely independent of IT to in conducting their own clinical studies.

The next benefit is pay-as-you-go. Today, the EDC vendor, or whoever is providing hosting services, charges you for development, customization, and study build. When the EDC system goes live, it is often the case that there aren’t any subjects yet enrolled in the study. A sponsor could be paying thousands of dollars per month while subjects are slowly being enrolled. With the Cloud, sponsors pay for what they use when they use it. If you don’t have any subjects enrolled yet, you don’t pay. I believe this will go a very long way to cutting R&D costs.

The third advantage is elasticity because with the cloud you aren’t required to keep buying and deploying your hardware and resources for every clinical trial. The cost of managing this hardware is very expensive and so the question is, what happens to this hardware when the trial is done? You probably want to re-purpose this hardware, but by the time your clinical study is over, technology will have evolved: CPUs are faster, the discs are denser and the networks are faster. When the clinical trial is over, you are either stuck with this dated equipment, or forced to purchase expensive new hardware for your new clinical trials.

If you compare this to the cloud approach, the first major difference is that you don’t need to buy the hardware. This is a huge benefit, especially for start-ups because there is no need for high capital expenditure. Also, you aren’t required to purchase extra resources for your increased demand. If you do need to add additional computing resources, the Cloud infrastructure will automatically allocate said resources. When demand shrinks, resources are automatically deallocated.

This is similar to managing a corporate car fleet. Suppose your company has five employees each working in five different territories and it gives a car to each of them to cover said territory. The company has the choice to either buy the cars, or rent them. Renting the cars is very similar to the Cloud approach. For example, if your company grows to 50 sales reps, a rental company can automatically increase the number of cars you need, you don’t have to buy 50 more cars. Also, if for some reason your sales force shrinks to 20, you can simply release those cars. Elasticity is key in order to grow and shrink the computing resources as demand requires.

You can download the audio and PDF to Marc's entire interview here.

Monday, July 21, 2014

Integrating Sample Inventory and Bioprocessing Data: Collaborative Technology Solutions

This post was contributed by Lori Ball, COO, BioStorage Technologies

With an increasing amount of biomaterials collected and stored for research initiatives around the world, cataloging, tracking and ensuring chain-of-custody of these scientific assets and their associated data have become paramount to optimizing sample utility for prospective research and retrospective analysis.

Advanced technology and data virtualization can be an enabler for driving sample optimization by bridging sample data across multiple platforms. Specifically, sample management inventory databases can support the compilation and analysis of genetic and clinical data on an unprecedented scale, leading to improved sample selection and optimization in research.   

As an example, BioStorage Technologies began a collaborative partnership with one of the largest biopharmaceutical companies in the world to create a custom data management solution that integrated sample inventory data with bioprocessing data to support biomarker development.  The company’s ISISS® (IntelligentSpecimen Inventory Storage System) was leveraged by the biopharmaceutical client and expanded to support the collection and connectivity of sample inventory data with bioprocessing data. The resulting technology solution provided the research company with customized user access controls, sophisticated search functions, reporting formats, and specific tracking features.

Technology experts within the biopharmaceutical company utilized their existing systems expertise to guide the design process for this customized solution.  The development of the integrated technology solution was achieved through an innovative BioProcessing Solutions Alliance between BioStorage Technologies and RUCDR Infinite Biologics.  This alliance enabled genotype data elements and other bioprocessing data generated by the biopharmaceutical company at RUCDR Infinite Biologics to be integrated and stored with sample inventory data already being held in ISISS®. 

Integration of sample inventory and bioprocessing data through the use of innovative technologies represents an opportunity to improve the selection and maximize the utility of high quality samples in order to achieve research efficiencies and support biomarker research. The ultimate goal of leveraging technology within research is to improve decision-making and advance new therapies to the market faster.

Learn more about this collaborative case study at IIR’s upcoming Biorepositories and Sample Management Conference where we will further explore the methods and best practices used during the development of this innovative sample management technology solution:

How to Use Technology to Drive Quality: Insights into an Innovative Sample Management Project
September 9th 10:15-10:45am
Lori Ball, Chief Operating Officer, BioStorage Technologies
Phil Waters, Data and Informatics Specialist, Genetics Sample Management, GlaxoSmithKline

Want to learn more about the Biorepositories and Sample Management ConferenceDownload the agenda to see what’s on tap. 

SAVE $100 as a reader of this blog. Register here and use code XP1998BLOG.

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Friday, July 18, 2014

Who can you meet this year at Partnerships in Clinical Trials Asia?

The 6th Annual Partnerships in Clinical Trials Asia at the Sheraton Shanghai Hongqiao, China on 16-18 September 2014 addresses the partnership opportunities in Asia, the critical challenges faced and solutions to ensure the success of Clinical Trials and partnerships in Asia. 150+ attendees from 10+ countries attend this annual conference to network, partner and hear real-world insights from thought leaders from leading pharmaceutical and biotech organizations.

Do more business in 3 days than in the rest of the year by networking with 150+ clinical decision makers. PLUS! Maximize your engagement via speed networking, open roundtable discussions and VIP luncheon opportunities Partner, Network & Learn from Decision Makers from Attending Companies, including:

Allergan Biologics * Asia Training Consortium * Aslan Pharmaceutical * Astrazeneca * Baxter * Bayer Healthcare * Beigene * Beijing Jingwei Chuanqi Medicine Services Co Ltd * Boehringer Ingelheim * Cadila Pharmaceuticals * CLS Communication Shanghai Co Ltd * Covidien * Eli Lilly * F. Hoffmann-La Roche Ltd * Food & Drug Administration * Glaxosmithkline * Gorege Clinical * GSK China Investment * Hinova Pharmaceuticals * Inje University Busan Paik Hospital Clinical Trial Center * Jiangsu Hengrui Medicine * Johnson & Johnson China * King Saud University * Lundbeck * Mallinckrodt Pharmaceuticals * Mebiopharm * Merck * Ministry of Health * National Agency for Food and Drug Administration & Control (NAFDAC) * Otsuka Pharmaceuticals * Oxford University Clinical Research Unit * Peking University People's Hospital * Pfizer * Pfizer R&D Center * Proswell Medical Company * Roche * Roche Diagnostics * Sanofi * School of Medicine, Tsinghua University * Takeda Development Center Asia * The University of Hong Kong * United Therapeutics * VDDI Pharmaceuticals * Wanbang Biopharmaceuticals * WuXiPRA

Want to meet representatives from these companies and more? Register to join us. And don’t forget that as a reader of this blog, you can save 20% off the standard rate when you register to join us and mention code XP1975LINK.

Have any questions about the event or want to get involved? Feel free to email Jennifer Pereira.

Thursday, July 17, 2014

Partnerships Asia Session Spotlight: Clinical Trial Design and Compliance – Medical Devices vs. Pharmaceuticals

In 2011 in the United States alone, there was between $95 and $105 billion spent on medical devices.  This is a significant amount of the $200 billion that was spent worldwide on these devices according to  How are medical devices defined in the United States?
  • - Diagnoses, cures, lessens, treats, or prevents disease
  • - Affects the function or structure of the body
  • - Does not achieve primary intended purposes through chemical action
However, regulations across different countries present different rules and regulations for clinical trials across the world.  This September at Partnerships in Clinical Trials Asia, we'll be looking at how these devices are defined and conducted in Asia.

Featured Presentation: Clinical Trial Design and Compliance – Medical Devices vs. Pharmaceuticals
Featured Presenter: Timothy Low, Vice President, Medical Affairs Asia Pacific, Covidien, Singapore
About the session: 
  • - Examining the differences between medical device and pharmaceutical trials
  • - What are the medical device trial design considerations?
  • - Compliance – GCP vs. ISO14155
Partnerships in Clinical Trials Asia will take place this September 16-18 in Shanghai, China.  For more information on this session, download the agenda.  As a reader of this blog, when you register to join us and mention code XP1975BLOG, you'll save 20% off the standard rate.

Wednesday, July 16, 2014

Early Stage Clinical Trials

The most complete study of clinical success rates may be even lower than previous estimates. According to a report from Nature Publishing Group, Hay and colleagues conducted a detailed analysis of phase transitions of 4,451 drugs with 7,372 independent clinical development paths from 2003 to 2011. The successful transition rate from Phase I to Phase II was 60% in the period of 1991–2000. Only 32% of the drug successfully made the transition from Phase II to Phase III. On average, the likelihood of reaching FDA approval (LOA) from Phase I was about 10%. Thus, the Contract Research Organizations (CROs) outsourcing services market has witnessed significant growth in the past decade. This growth has been attributed to the rising costs involved in conducting various phases of clinical trials ranging from drug discovery up to post-marketing approvals. 

This fall at Partnerships in Clinical Trials Asia, we'll gather a group of experts including Duanghatai Chirapathomsakul, Associate Director Global Clinical Quality Assurance, Lundbeck from Thailand and John Gong, Senior Vice President, Clinical Operations, Beigene of China to participate in the panel discussion Quality Driven Drug Development in the Asia Pacific Region to talk about bringing drugs from discovery and through the clinical trial phases.  For more information on this session, download the agenda.  If you'd like to meet and network with these panelists this September 22-24 in Shanghai, as a reader of this blog, you can save 20% off the standard rate when you register to join us.

Tuesday, July 15, 2014

Medical device clinical trials to be made mandatory in India

Medical device clinical trials are changing in India.  Recently announced, according to the Deccan Herold, clinical trials will follow the same lines as those of vaccines and medications.  Those devices which came out between the years of 1989 and 2005 will also have to undergo clinical trials.

Announced July 3, the following will now need to have clinical trials: disposable hypodermic syringes and needles, cardiac stents, drug eluting stents, catheters, bone cements, heart valve, intra-ocular lenses, intra-venous cannulae, orthopaedic implants and internal prosthetic replacements.

Industry representatives will meet with governing officials to clarify questions they have.  Many of the clinical trials needed for products that have been on the market for years.  They also want to discuss the differences in medical devices and drugs and how different regulations are needed to better suit the products on the market.

This September in Shanghai, we'll have a special round table focus lead by Jimmy Lu, Senior Clinical Specialist, Roche Diagnostics, China to look at medical device clinical trials in a different country - China.  Sign up to join us at the roundtable  How to Conduct Medical Device Clinical Trial in China when you register to join us at Partnerships in Clinical Trials Asia this September 16-18 in Shanghai, China.   Find out more about this roundtable and this year's program by downloading the brochure. As a reader of this blog, when you register to join us and mention code XP1975BLOG, you'll save 20% off the standard rate. 

Do you think that medical devices and drugs/vaccines should have the same standards when conducting clinical trails?  Why or why not?

Friday, July 11, 2014

Clinical regulatory challenges in India

India is an ideal place for clinical trials for many reasons.  However, there are many regulatory hurdles that companies face when considering going into the country to start their trials.  Pharma Focus Asia recently broke down a few of the issues they see in terms of regulatory challenges in the country:

  • - Shortage of regulatory experts: While there are regulatory documents, the country does not release guidance to help the professionals interpret the documents.  Experts often come to multiple conclusions about the guidances.
  • -There is a difference between Indian GCP and ICH-GCP.  India has specific rules including consent procedures, compensation for participation, as well as the roles and responsibilities of foreign sponsors conducting clinical trials in India.
  • -Phase 1 studies can not be conducted in India if the research on the medication has not been done within the country
Throughout the article, they also look at the challenges of the ethics committees, the liabilities of clinical trials (whether they lay on the sponsor or the CRO), access to drugs for the patients after the clinical trial, and no acts or laws to monitor clinical trial progress in the country.

Regulatory challenges follow clinical trials wherever they go.  This fall at the Partnerships in Clinical Trials Asia event, regulators from Vietnam, India, Malaysia and Nigeria will join us for the panel Global Regulatory Updates for Clinical Trials to share insights on their countries and discuss topics such as the different regulatory standards, international standards, ethical and cultural diversity issues and more.  Find out more about this session by downloading the agenda.  If you'd like to join us September 16-18 in Shanghai, as a reader of this blog, when you register to join us and mention code XP1975BLOG, you'll save 20% off the standard rate.

What is your company's biggest challenge when it comes to facing different regulatory rules across different countries when conducting clinical trials?

Thursday, July 10, 2014

Optimizing Samples for Future Use: Innovative technology to improve the functional quality control of DNA samples

Biobanking is an exact science to say the least and requires a very technical approach.  Without a true, accepted set of best practices to go by, it becomes important to draw on the knowledge and experience of others.  Join us for a live one-hour webinar with Dr. Andrew Brooks, COO of RUCDR Infinite Biologics, and Dr. Tatiana Foroud, Director, Division of Hereditary Genomics and a P. Michael Conneally Professor of Medical and Molecular Genetics at Indiana University as they cover some of their latest experiences in the industry.

What you’ll learn
  •    - Reinforce the integrated, high-science approach to biobanking and bioprocessing services provided by the BioProcessing Solutions Alliance
  •    - Discuss the benefits of conducting DNA and RNA functional quality control analysis of samples to support improved storage and selection of samples for downstream analysis
  •    - Provide a research client perspective on the need for high-quality samples to support translational research
  •    - Provide examples of how functional quality control analysis of nucleic acids using SNPtrace™ technology has improved the selection of samples to support downstream applications
Date: Monday, 8/4
Time: 2:00 – 3:00 EST
Cost: FREE
Code: XP1998BLOG

About the speakers

Andrew Brooks, Ph.D.
As Chief Operating Officer of RUCDR Infinite Biologics, Dr. Andrew Brooks oversees the operations of laboratories within RUCDR, ensuring consistent and superior quality standards for all services.
Since joining RUCDR, he has worked to automate and develop the service infrastructure to provide high throughput sample management and analysis for DNA, RNA and protein-based technologies to hundreds of labs globally. His methodologies extend the use of valuable samples by extracting and renewing limited quantities of biomaterial with newly developed technologies.

Dr. Brooks is a well-recognized genomicist and has developed and implemented cutting-edge, molecular-based technologies for nucleic acid and protein analyses.  As a molecular neuroscientist, his research focuses on deciphering the molecular mechanisms underlying memory and learning.
Dr. Brooks is an Associate Professor of Genetics at Rutgers, The State University of New Jersey. He received his Ph.D. from the University of Rochester, School of Medicine.

Tatiana Foroud, Ph.D.
The central focus of research in Dr. Tatiana Foroud’s laboratory is the identification of genes contributing to disease. Ongoing studies are focusing on a variety of disorders including Parkinson disease, Alzheimer disease, intracranial aneurysms, alcohol dependence, and cancer. The tools that are currently being employed for gene identification include the genomewide association approach which evaluates millions of SNPs throughout the genome to identify relatively common variants contributing to disease susceptibility. Another approach being utilized with increasing frequency is sequencing – currently of the exome – to identify rare variants that have large effects on disease risk. Dr. Foroud’s research group utilizes statistical approaches to analyze the large amounts of data being generated.

Dr. Foroud is a Director, Division of Hereditary Genomics and a P. Michael Conneally Professor of Medical and Molecular Genetics at Indiana University and currently teaches two of the courses in the Hereditary Genomics Division. She received her Ph.D. from the Indiana University School of Medicine.

Want to hear more from Dr. Brooks? Catch him at the Biorepositories and Sample Management Conference.  Join us September 8-10 in Boston, MA. Download the agenda to see what’s on tap.

SAVE $100Register here and use code XP1998BLOG.

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Need to know more about clinical trails in China? Four Reasons You Need To Be At Partnerships in Clinical Trials Asia

Asia, particularly China, has risen to the forefront as a top clinical trial destination. With service providers maturing, this region now offers an alternative to traditional emerging regions, for example, Eastern Europe or Latin America.

Partnerships in Clinical Trials Asia will bring to the forefront many of the opportunities, insights and must haves when conducting clinical trials in the Asia Pacific region.  Here's what you can gain by joining us:
  • • Have a clear insight of both the current state and future growth potential of the market in China
  • • Understand the Chinese industry including its current strengths and weaknesses, advantages and disadvantages for outsourcing clinical trials
  • • Discover how big pharmaceutical companies overcome challenges brought by regulatory and cultural diversity hurdles in China
  • • Streamline your supplier pool by evaluating CRO, tech and other clinical providers all in one place 
  • Access for 3 days to 150+ clinical decision makers from China and surrounding Asia, through the new addition of partnering360® (an online networking tool),speed networking, open roundtable discussions, and VIP lunch meeting opportunities.
Find out more about the opportunities at this year's event by downloading the agenda.  If you'd like to join us September 16-18 in Shanghai, as a reader of this blog when you register to join us and mention code XP1975BLOG, you'll save 20% off the standard rate.

Tuesday, July 8, 2014

How many teenagers are falling through clinical trials age gaps?

Too many according to a study from the  National Institute for Health Research and Teenage Cancer Trust.  Broader age ranges lead to more patients of  young adult and teenage range participating.  Not only that - but many often do better in the long run because of the specialized care they receive while participating in the clinical trial.  Implementing a broader age range limit, the UK saw the number of teenagers (15-19 year olds) participating in clinical trials rise 13% from 2005-2010.  As for those 20-24 year, there was a 5% increase in participation to 18%.

According to the article, with a full spectrum of healthcare workers sharing information about clinical trials, everyone benefits:
“By encouraging doctors to take into account the full age range of patients affected by individual types of cancer, we’ve shown that it’s possible to design trials that include teenage cancer patients and, importantly, that better match the underlying biology of the disease and the people affected.”

Read the full article here.

The UK has taken the right efforts to expand age rages of those who participate in clinical trials. What are some of the reasons you think clinical trial age ranges should be expanded?

Thursday, July 3, 2014

Celebrate America and Biorepositories! Register Thursday & Friday and save 30% off the standard rate!

Let freedom ring! Celebrate America’s freedom and YOUR freedom to register for the 7th Annual Biorepositories & Sample Management Conference with a 30% discount off the standard rate!*

Register to join us and mention codeXP1998JULY4 to take advantage of this discount.

Biorepositories & Sample Management Conference will take place September 8-10, 2014 in Boston, MA. Visit the website for full details.

Have any questions? Email Jennifer Pereira.

*This promotion is only valid July 3 & 4, 2014

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Wednesday, July 2, 2014

Electronic Data Capture pays off for clinical trials

Converting to electronic data capture is something that may be challenging for many companies, however, Partnerships in Clinical Trials sponsor Clinovo recently published a paper examinnig the top reasons why making the switch from traditional paper data capture to an electronic system saves time, money and can ultimately bring products to market faster.

What are the top reasons for Electronic Data Capture?
  1. 1) Cost savings
  2. 2) Time saving
  3. 3) Cleaner data and reduced quearies
  4. 4) Tracibility
  5. 5) Simplified modeling
  6. 6) Reduced time on data entry
  7. 7) Reactivity
  8. 8) Reusability 
  9. 9) Mid-study changes
  10. 10) Patient Safety

Using electronic data capture allows for those running the trial to see patterns in data faster allowing for changes to be made in the clinical trials while they are taking place. There is also the benefits of using less paper, straight data entry into the system create fewer data errors, and saves money on paper and printing costs. However the benefits are not without their challenges. Electronic data capture systems are expensive and there are challenges within the work force of adapting to the new system. Data privacy is also another major concern with electronic data.

Read Clinovo's full report here.

Tuesday, July 1, 2014

Business Challenges for Biobanks in iPSCs

This post was contributed by @MikeMadarasz

The business of banking induced pluripotent stem cell (iPSC) lines certainly has the potential to improve efficiency in cell line development.  The presence of a growing number of these iPSC banks online are proof of this potential, however these companies are still working to overcome some of the challenges posed by the business model of the industry. 

iPSCs are considered advantageous to some traditional cell engineering techniques because in practice, they simulate primary cells taken directly from test subjects very well.  They are, however, notorious for requiring a great deal of attention to maintain and store. 

Banking iPSCs can be a tricky business model
There's great opportunity in iPSCs 
About three years ago, the NIH’s Center for Regenerative Medicine launched a program lead by Mahendra Rao to deposit and distribute cell lines contributed by a network of biorepoistories.  Rao explained the model, something he referred to as “crowdsourcing”, as a quite successful.  Said Rao in a recent article, “If you look worldwide, the largest number of lines that have been distributed have been from the U.S., from these nonprofit registries at which NIH has taken a leadership role in depositing the lines.”

The real question for these organizations becomes how to choose which lines to derive iPSCs as companies try to avoid holding onto a surplus that no one wants.  The biggest difficulty of this model has become trying to project not only which lines will be most in demand, but more profitable as well.  Economically, it makes the most sense for companies to concentrate on niche categories. 

Said Michael Yaffe, associate director for research activity at California Institute for Regenerative Medicine in the same article, “We wanted to make as many [cell lines] as possible. Then it became an economic argument: How many could we afford and how much could we push a deriver to handle?” 

“If a few large pharmaceutical companies buy a complete set of all the lines, that would keep the bank established and running for many years,” continued Yaffe. “If academic researchers are going to buy a few lines at a time or a few lines each, it will create some challenges for the sustainability of the bank.”

Despite these difficulties, the field is projected to continue to grow.  Rao estimates there are between 200 and 250 lines in existence in current repositories and expects that number to quadruple in the next year.  If companies can continue to streamline these business models, it certainly seems that there is a profit to be had.  

We’ll have more on the latest in biobanking at the Biorepository and Sample Management conference. Join us September 8-10 in Boston, MA. Check out what we’ve got on tap.

Save $100 as a reader of this blog. Register here with priority code XP1998BLOG.

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Partnerships Asia Spotlight:Innovative Approaches to Clinical Partnering

With a goal to become one of the leading researchers in the UK, two hospitals in Bradford, England have put an emphasis on clinical trials in their hospitals.  According to Telegraph & Argus, hospital trusts from the The National Institute for Health Research Clinical Research Network have spearheaded the increase in clinical trials. Recent numbers released by the NHS has increased trials in the two hospitals from that region from 182 to 209.  Knowing that research is the spearhead to getting the new and best treatments to your patients, the hospitals encourage everyone on their staff to be knowledgeable about clinical trials and encourage the patients to strive for the best care - which happens in the units where clinical trials are taking place.  Innovation and improved patient care are two of the driving forces to making this increased number a success.

In this case, the hospitals have partnered with the employees to encourage and educate the patients about clinical trials.  This September at Partnerships in Clinical Trials Asia, United Therapeutics will join us to look at this very topic and how to get the knowledge to the write touch points to get patients into clinical trials during the presentation Pharma – Investigator Collaboration: Meeting Needs Through Motivation.

Featured Presentation: Pharma – Investigator Collaboration: Meeting Needs Through Motivation
Featured Presenter: Hassan Movahhed, Senior Vice President, Global Development Operations, United Therapeutics, USA
About the session: Collaborating with investigators is a key element to clinical trial success in China. Through a proven process, United Therapeutics has been able to build a plan to engage with investigators and site staff in clinical trials in China.

  • • Building a Toolbox for CROs
  • • Answering the question of what drives Investigators and how can we fulfill those needs?
  • • Creating a customized engagement program within the constraints of typical benchmarks
Find out more about this year's program by downloading the agenda.  If you'd like to join us September 22-24 at the event, as a reader of this blog, when you register to join us and mention code XP1975BLOG, you can save 20% off the standard rate!

Monday, June 30, 2014

Celerion expands in to Asia and finds partners for success

This year, Celerion, they bring their expertise in early stage clinical trials and bioanalysis while the KDDF will profit by working with a company who can bring their Korean drug discoveries to a global market.
Celerion has put an emphasis on taking their clinical research to Asia and finding partners in the local regions for success. Earlier this year, Celerion expanded in to South Korea with a partnership with Korean Drug Development Fund (KDDF) which unites government, industry and academia. In this partnership, according to

To continue their focus on Asian expansion, earlier this month, Celerion also announced their expansion in to Singapore.  The country - which has a very centralized location between India, Japan and Australia, the company has started by hiring Chew Lan Chong, a veteran of more than 130 early studies sponsored by the likes of Pfizer ($PFE) and Eli Lilly ($LLY), to serve as executive director and lead its new outpost.  According to FierceCRO, the company will join forces with expertise in pharmacogenetics and ethnic bridging studies. The country is taking measures to invest in biotech, the demand is high and Celerion has joined Covance, Parexel and others in the region for conducing clinical trials.

This September in Shanghai, the Partnerships in Clinical Trials Asia conference will bring together experts from across the field to spend an afternoon focusing on optimizing clinical relationships and collaboration.  In the session Innovative Approaches to Clinical Partnering, an interactive panel will feature representatives from Sanofi, Roche, Merck and Beigene to discuss determining pros and cons of partnering with local vs. global SMOs & CROs, maintaining relationship and generating good quality supporting protocols and more.  Find out more about this session by downloading the agenda.  If you'd like to join us this fall in Shanghai, as a reader of this blog, when you register to join us and mention code XP1975BLOG, you can save 20% off the standard rate.

Wednesday, June 25, 2014

Call For Speakers: 24th Annual Partnerships in Clinical Trials Conference

The Institute for International Research is looking for speakers for our upcoming 24th Annual Partnerships in Clinical Trials Conference, to be held April 21-24, 2015 in Boston, MA.

We are currently recruiting pharmaceutical/biotech/medical device professionals in the clinical operations, outsourcing, data management and innovation field who can share NEW DATA through detailed case studies on the following topic themes:
  • • Risk-Based Study Management
  • • Operational Implication of Risk Sharing Collaborations
  • • Implementing Clinical Innovation
  • • New engagement Models in Patient/Site Interactions
  • • Data Transparency
  • • Efficiencies in Strategic Partnerships (Pharma/CRO; Pharma/Pharma; Pharma/Academia)
  • • Clinical Operations in Global Trials
  • • Partnering with Payers in Clinical Development
  • • Innovative Outsourcing Strategies

We invite you to submit a proposal for a speaking opportunity directly to Marina Adamsky by email, by August 1, 2014.

Abstract Requirements:
  • • Title
  • • Speakers (can be proposed)
  • • Brief description
  • • 3-5 discussion points
  • • No longer than 1 page
Thank you and we look forward to welcoming you to Boston in April!

Have any other questions about this year's event?  Emal Jennifer Pereria.  Do you want to stay up to date on the latest updates for the 2015 program?  Be sure to subscribe for email updates!

Thursday, June 19, 2014

Partnerships Asia Spotlight: Developments in Informed Consent for Improved Patient Outcomes

Yesterday, we looked at what needs to be included in the informed consent process so that patients fully understand what they're getting themselves into.  When it comes to informed consent in the developing nations of Asia, it's important to understand both the sites that are conducting clinical trials as well as the participants.  In an article at DDN News, they look at the informed consent process and the challenges it imposes in Asia.  As many of the developing countries already have challenges with resources - properly completing the informed consent process in a way that the patients also understand is difficult.

This September at Partnerships in Clinical Trials Asia, we have a panel of experts in the Asian region who will be calling to discuss this topic in depth in the panel discussion Asian Developments in Informed Consent for Improved Patient Outcomes.

Featured Session: Developments in Informed Consent for Improved Patient Outcomes

Featured Panelists: 
  • Bhaswat Chakraborty, Senior Vice President & Chair Scientific Committee,
  • Cadila Pharmaceuticals, India
  • Carlos Linn, Asia-Pacific Regional Medical Director, Diversified Products, Pfizer, China
  • Joan Shen, Chief Medical Officer, Jiangsu Hengrui Medicine, China
  • Henry Yau, Managing Director, Clinical Trials Centre, The University of Hong Kong, Hong Kong
In this session, the panelists will discuss:
• Assessing the best strategy in obtaining informed consent
• Considering language and culture differences and the associated translation requirements
• Embracing new technologies to streamline the informed consent process

Partnerships in Clinical Trials Asia will take place September 16-18 in Shanghai, China. As a reader of this blog, when you register to join us and mention code XP1975BLOG, you'll save 15% off the standard rate.

Wednesday, June 18, 2014

The Informed Consent Process: What needs to be included?

Patients understanding what's going on during a clinical trial is key to the participant.  That is why the informed consent process is critical and each patient participating in the clinical trial must understand what is going on in the trial and why it's taking place.

Forte Research Systems recently looked at four key items that need to be addressed in the informed consent process that should take place no matter what the trial or who the participants are - whether they are children, the mentally challenged, seniors or other demographics.  Everyone should understand these four key things no matter what the trial: what the trial is for and how it's run, the risks and potential benefits of participating in the trial, the responsibilities and confidentiality needed to ensure a smooth trial and that the trial they're participating in is voluntary.  Also, depending on the trial, it's important to communicate the additional information needed to understand the trial critical to the patient.

When you're working with patients, what are some of the information roadblocks that occur with patients when working on the informed consent process?

Tuesday, June 17, 2014

Biorepositories and Sample Management Conference: Brochure Now Available

IIR’s Biorepositories and Sample Management Conference
September 8-10 | Boston, MA

"According to a Visiongain study, the world market for human medical biobanking will reach $24.4 billion in 2017, and expand strongly to 2023."

The quality of your samples can determine whether you will be forced to repeat clinical trials or reproduce their results as well as the potential fallout from adverse events.

Attend the 7th Annual Biorepositories and Sample Management Conference to examine the industry's most pressing topics, benchmark best practices with your peers and ultimately learn how to maximize the value of your biospecimens through quality-driven biobanking.

Download the brochure to view the full agenda.

New additions for 2014 include:
  • - 11 fresh case studies from companies like Pfizer, BMS, AZ, GSK, NIH and more!
  • - 2 Interactive pre-conference workshops on Informed Consent and Quality of Tissue Specimens for Research
  • - Peer-to-peer knowledge exchange using the event-specific networking tool on partnering360 

The 7th Annual Biorepositories and Sample Management conference will take place September 8-10, 2014 in Boston, MA.  As a reader of this blog, you can save an additional $100 off the current rate when your register to join us and mention code XP1998BLOG.  Visit the webpage to find out more and to register.

Have any questions or want to get involved? Reach out to me at or on Twitter @MikeMadarasz. 

Friday, June 13, 2014

Partnerships in Clinical Trials Europe 2014: Brochure now available

Brought to you by the organizers of the world-renowned Partnerships in Clinical Trials events in the US, Europe and Asia, we're thrilled to unveil the conference brochure for the 13th Annual Partnerships in Clinical Trials Europe. Creators, innovators, storytellers and rising stars will come together on November 5-6, 2014 at the CCIB, Barcelona, Spain to provoke change and demand solutions to advancing clinical trial collaborations.

PCT delivers new value every year:
  • • 100+ speakers: Large, mid-size, small, SME pharma & biotech, CROs, vendors, AROs, patients, sites, Private Equity
  • • 100+ sessions: 3 special focus day streams and 8 new content streams
  • • 15+ hours of networking: Make new important industry contacts and catch-up with your peers
  • • The Partnerships Bar: Continue your discussions over a drink in our fantastic new PCT bar!
  • • Find potential new partners to connect with and meet through partneringONE® - the leading conference networking solution for the life sciences
  • • 50+ brand new case studies
Find out what Europe's leading annual partnering event for the clinical outsourcing community has in store for 2014.

Plus - back by popular demand we have industry flash rates starting at just £999* (*T&Cs apply) for a 2 day conference pass.

The vibrant city of Barcelona is the perfect city in which to forge new partnerships and enrich existing ones - and have some fun! We hope to see you there.

Have any questions? Feel free to reach out to me at

*T & C's Industry Flash Rate:
1. Pharma only until 29th August 2014
2.Offer only applicable to employees of pharma and biopharm companies
3.Only applicable for the 2 main conference days and not available on add-on days
4.Not applicable to supplier/vendor companies. Informa Life Sciences will verify whether you are a vendor/supplier when your registration is processed

Thursday, June 12, 2014

Biobanks to Receive $12M in Funding From NCI

This post was contributed by @MikeMadarasz

Several institutions can expect an influx of funding to support the development of new biobanks according to a report from GenomeWeb.  Per the report, the National Cancer Institute will award as much as $11.8M next year to fund the creation of new biobanks that will “collect, store and distribute” samples from cancer as well as related data to those involved in the National Clincal Trials Network.

On Friday, the NCI said that it will provide as many as five institutions with as much as $3.1M per year.  The funding will support the creation of the NCTN Biospecimen Banking Resource and will serve four adult NCTN groups as well as one pediatric group.  The specimens at these banks will be donated by patients involved in Phase III and Phase II clinical trials funded by the NCI.  These samples will include tissue, blood, and many other types of biological fluids from NCTN group member hospitals as well as affiliated institutions. According to the report, they will involve a range of solid and malignant tumor types.
Biobanks could soon be seeing green

You can find the full article from GenomeWeb here.

We’ll have more on the latest in biobanking at the Biorepository and Sample Management conference.  Join us September 15-17 in Boston, MA.  Check out what we’ve got on tap, download the brochure here

Save $100 as a reader of this blog. Register here with priority code XP1998BLOG.

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Wednesday, June 11, 2014

Partnerships Asia Session Spotlight: EHRs, Confidentiality, Data Security & Protection of Patient’s Records

This past October, the Vietnam Health Ministry invested VND100 billion (US$4.7 million) on one of their biggest initiatives to date - investing in electronic health records. In this initiative, 40 of the biggest hospitals in the nation will participate in the digitization of the health records in their country. While there are many challenges facing this effort, Asia Pacific Future Gov shares that there are many factors working in the favor of kicking off electronic health records in the country: infrastructure, technology-savvy population, and cheap internet costs provide strong support to the initiative.

Vietnam is not the only country in Asia facing this challenge.  At the Partnerships in Clinical Trials Asia conference, we bring the professionals in the region dealing with the same issues to one place to form a three day community of networking and discussion around topics facing clinical trials professionals in the region.  Coming this September, among other challenges facing the Asia Pacific region in clinical trials, we'll be looking at the challenges and implementation of electronic health records and patient safety in Asia.  Our featured session of the day is EHRs, Confidentiality, Data Security, & Protection of Patient's Records.  

Featured Session:  EHRs, Confidentiality, Data Security & Protection of Patient’s Records
Featured Speaker: Arun Maseeh, Vice President, Medical Affairs, Cadila Pharmaceuticals, India
About the Session:  This session will cover go over the following topics: transitioning to Electronic Health Records, Dealing with different data privacy rules, retrieving patient medical records efficiently, and getting patient informed consent.

Find out more about this program by downloading the agenda.  If you'd like to join us this September 16-18 in Shanghai to meet with some of the top minds in the clinical trials industry, register to join us at Partnerships in Clinical Trial Asia with the discount code XP1975BLOG and save 20% off your registration!

Monday, June 9, 2014

The push for Electronic Health Records and Culture Barriers in Asia

How are physicians using the new electronic tools that are available to them in today's healthcare efforts? Doctors are using them more than ever and each device is used to cater to a different need of the physician providing the care.  In a study detailed at HIT Consultant, they share that of 300 surveyed professionals, 80% use mobile phones in their day to day practices.  Those mobile phones are primarily used to look up drug information.  As for tablets, 61% of physicians are using them.  Their primary use is to access medical research.  There are 55% of physicians using both devices in their practices.

Laptops and desktop computers still have a use.  Physicians use them to chart information and to access and interact with information in electronic health records.  However, as expressed by physicians in research, the desire is to easily transition to be able to use EHRs on tablets.  Patient safety and improved care are at the center of this desire to have easier access to this secure, personal data.  Not only are those two things improved, but it's also easier for physicians to access clinical data which means better answers to questions that are posed outside of the traditional doctor/patient medical setting.

How do the EHR numbers look in Asia?  In Hong Kong specifically, creating quality and effective EHRs has become a part of of the effort to create high quality and effective public health care in the country.  However, there is a missing link between public and private hospitals as most of the private hospitals are still using paper records so there is no crossover between the two systems.  In order to rectify this, the Food and Health Bureau of the country has set up an EHR office.  Although there is a Personal Data Protection Ordinance, there is no specific EHR regulation to dictate how patient privacy is maintained specifically to electronic health records.  Another concern in the region, according to Poon, Wai-yin' Thesis Review of the implementation of electronic health record in Hong Kong, Hong Kong is also seeing a rise in the use of Chinese medicine and there is currently no crossover between the two types of care on these electronic health records.

This September at Partnerships in Clinical Trials Asia, Arun Maseeh, Vice President, Medical Affairs, Cadila Pharmaceuticals, India will join us to look how EHRs are being adopted in various Asian countries and how patients data is being protected.  For more information on this session, download the agenda.  If you'd like to join us September 16-18, 2014 in Shanghai, China, as a reader of this blog, you can save 15% off the standard rate when you register to join us and mention code XP1975BLOG.

What do you see as one of the biggest challenges of implementing electronic health records across the various practices and cultures of Asia?

CluePoints to Launch New Web Application for Risk-Based Monitoring

Partnerships in Clinical Trials parter CluePoints, a leading provider of Centralized Statistical Monitoring (CSM) solutions for clinical trials, has announced a web-based version of its intelligent risk-based monitoring platform that enables sponsors to determine the quality and integrity of their clinical trial data. The web-based CSM software as a service (SaaS) offering will enable customers to control the upload of clinical data for assessment, visualize the findings and interact with analyses to make the understanding of results, comprehension of signals and identification of issues as intuitive as possible.

CluePoints' solutions are driven by the company's intelligent, patent-pending SMART™ engine that provides customers with the ability to check data quality across all clinical subjects, sites, regions and countries involved in a trial, achieving data consistency, while documenting where and why any anomalies have occurred. Aligned with current FDA and EMA recommendations, the approach ensures that users are able to identify signals in study datasets and can make timely decisions about which sites to target for monitoring activities, resulting in reduced regulatory submission risk and costs.

This first version of the web portal aims to put the sponsor in control so that they can run the analysis, set-up the SMART engine, construct and manage data within the system, select appropriate statistical tests and perform the complete CSM process independently and objectively. Continuous improvements will be brought to the software to meet clients’ needs: a second release will soon support closer to real-time assessments of data and generate a customized report whenever required.

"The launch of CluePoints' web-portal marks another exciting industry first for CluePoints as it enables sponsors and contract research organizations (CROs) to drive their own analyses using actual clinical data, rather than just subjective operational metrics, for the first time", comments Franҫois Torche, CEO of CluePoints. He continues: "We are continually working to enhance the usability of our solutions to meet current industry needs and through discussions with our clients have found that many companies would like to take full control of their risk-based monitoring analyses using clinical databases. The new SaaS solution enables them to do this."

To offer sponsors and CROs detailed insight into the practical implementation of CSM solutions, a new webinar from CluePoints in collaboration with Sanofi Aventis is now available online, entitled 'Risk-Based Monitoring – What we’ve learnt in a year, a Large Pharma Perspective from Sanofi'. The session demonstrates how CSM techniques have been harnessed to improve data quality and oversight, while showcasing the impact that Sanofi has had on enhancing this technology-driven approach. Download the webinar here.

For further information on CluePoints' solutions, please visit

About CluePoints
CluePoints® is a Central Statistical Monitoring solution that has been designed and perfected over the last 10 years. It employs unique statistical algorithms to determine the quality, accuracy and integrity of clinical trial data both during and after study conduct. Aligned with guidance from the FDA and EMA, CluePoints® is deployed to support traditional on-site monitoring and to drive a risk-based monitoring strategy. The value of using CluePoints® lies in its powerful and timely ability to identify anomalous data and site errors allowing improvement in clinical data quality, optimization of on-site monitoring and a significant reduction in overall regulatory submission risk.

Friday, June 6, 2014

How to manage conflict of interest and conflict of commitment when preparing for clinical trials.

Researchers and staff are often faced with competing demands on time and responsibilities. A "Conflict of Interest" occurs when an individual has the opportunity to use his or her position for personal financial gain or to benefit a company in which the individual has a financial interest.

A “Conflict of Commitment” exists when an employee's outside activities demand their time and attention to the point where it interferes with the individual’s responsibilities. It may also occur when a researcher on a clinical trial participates in competing obligations such as: working on another project, investing time in a new grant application, mentoring or peer review.

Conflicts of interests or commitments may not always be a concern; rather, the way in which the conflict is managed makes all of the difference. Researchers are expected to be transparent about how their time is spent and report any interests that may cause a potential conflict. By doing so, objective parties can review the nature of the disclosures and determine if any actions are required to remove the appearance of a conflict. Transparency of information combined with performance of due diligence helps protect all parties from any possible negative future actions.

Some organizations manage this process via paper which is very ineffective and opens them up to unnecessary risks and errors. Forward thinking organizations have implemented software solutions to manage and simplify their process while protecting themselves from undue consequences.

What are the benefits managing this process with COI software?
  • • Easy to use and deploy
  • • Reduces risk and costs
  • • Improves organizational effectiveness
How does it work?
  • • Automatically identifies potential conflicts
  • • Improves participant compliance levels
  • • Automates disclosure and review process
  • • Keeps an audit trail of actions
COI RiskManager: Disclose, Review, Report, Resolve.
  • • 30 day implementation
  • • No long term contracts
  • • 100% client retention
  • • Outstanding customer service

Contact Michael Vidoni for a demo: Phone 518-203-3995 or