Revisiting Partnerships 2010: Workforce Transformation: Leading Effective Cross-functional Teams in a Matrix Environment

Partnerships in Clinical Trials is taking place this March 30-April 1, 201a in Phoenix, Arizona. Every Friday leading up to the 20th anniversary of the event, we'll be recapping one session from Partnerships in Clinical Trials.

Workforce Transformation: Leading Effective Cross-functional Teams in a Matrix Environment

Workshop Presenters: Karen Sobel Lojeski, PhD, CEO, VIRTUAL DISTANCE INTERNATIONAL and Author, Uniting the Virtual Workforce and Leading the Virtual Workforce
Solomon Babani, Senior Director, Outsourcing and Vendor Management, CELTIC PHARMA DEVELOPMENT SERVICES

According to a recent study, 75% of the workforce will be virtual by 2012, “virtual” referring to those who work remotely, relying predominantly on electronic communication technology. More and more companies, particularly pharma companies, are turning to outsourcing and dispersed workforces to maximize efficiency, coverage and cost-effectiveness. While the advantages of PDAs, Bluetooth, social media and VPNs are obvious, the irony is, the more connected we become, the more isolated we are. This is the connectivity paradox described by Karen Sobel Lojeski in this morning’s workshop, “Workforce Transformation: Leading Effective Cross-functional Teams in a Matrix Environment.”

Trying to fit a 21st century style of working into a 20th century model creates what is called vertical distance, a perceived distance when electronic communications are relied on. Context is lost and a lack of “depth perception” can result in a decline in critical outcomes, job satisfaction, role clarity and a host of other areas. The three key factors that influence virtual distance are physical distance (geography, time zones), operational distance (technology, employee distribution) and affinity distance (culture, relationships and interdependence). Mitigating as many of these factors can diminish the overall negative impact of virtual distance. This means knowing when to have face-to-face meetings, upgrading communications technology to accommodate video, phone and Web conferencing, flattening hierarchies and making sure values are aligned across all company cultures.

Sobel Lojeski’s co-presenter, Solomon Babani, showed how his company, Celtic Pharma, has applied the lessons of virtual workforce so it works to their advantage. Rather than force a traditional business model to a virtual work environment, the company was built from the ground up on an outsourcing model. De-centralizing the planning and oversight and accountability and distributing it among a network of sub-suppliers, such as CROs, it effectively engages all parties and leverages their true core competencies.

As 21st business moves towards the inevitable – virtual workforces – an understanding of virtual distance factors and effective ways to mitigate them will be key to survival in this brave new world.

Written by Foreign Exchange Translation

10 Steps to Clinical Study Startup: Step 4 – Sending, Tracking, and Evaluating SFQs

Partnerships In Clinical Trials 2011 Media Partner goBalto has teamed up with this blog to bring you weekly perspectives on the clinical trials and outsourcing industry. We are very excited to present you with weekly contributions leading up to next year's event!

10 Steps to Clinical Study Startup: Step 4 – Sending, Tracking, and Evaluating SFQs

This is the fourth installment of our ongoing series on 10 Steps to Clinical Study Start Up. We hope you enjoy it. And of course feedback/comments/thoughts are welcome!

Introduction

It is standard practice for the sponsor or CRO to utilize the Site Feasibility Questionnaire (SFQ) to gain an initial assessment of the individual investigative site’s interest in and ability to work on their trial. This document will be circulated with far more sites than are required by the protocol. This really begs the question of how accurately these sites are targeted in the first place, but that is a different subject.

The only constant in this document is that it is almost always used to make an initial contact with potential sites for new clinical trials. Its content is highly variable and it can be a half page to more than 10 pages in length. It is common for this questionnaire to be sent in conjunction with a brief study synopsis. Unfortunately, at this point, without a CDA in place, the synopsis and questionnaire must necessarily be brief and vague. This will take its toll in the form of time-hungry follow up required later on when the Study Manager is sorting through responses and contacting various potential sites regarding the next step in their selection process.

The next step, as you may have surmised, is often another questionnaire. An intermediary step may exist where the CDA is distributed, signed, and collected. This will achieve the privacy requirements necessary for the sponsor to share more of, or a complete protocol. The next questionnaire will be detailed and specific with regard to the protocol. Following the mayhem of the questionnaire flurry, usually a pre-study visit, or pre-selection visit (or phone call) is scheduled.

Common Roadblocks:

Assuming the initial short list of investigative sites list targeted enough sites to fill the criteria for the individual protocol in question, one of the first challenges the study team will face is in the above-mentioned tracking process.

To add to the time-line and aggravation in this process it is common that study teams:

* Receive incomplete questionnaires, requiring additional follow up
* Receive no response by the deadline (It is common for sites to be asked to respond within 48 hours of receipt of the SFQ), requiring additional follow up
o A couple common reasons why the SFQ is late include:
+ Immediate lack of proper personnel to answer SFQ
+ Backlog of SFQs at sites. Often, because of poor early identification techniques, sites receive an inordinate number of SFQs, many of which pertain to studies inappropriate for their site.
* Receive inaccurate data*

*This problem merits further explanation. Sites are not intentionally trying to deceive the initiators of the SFQ; oftentimes they simply do not have enough information to adequately address the questions. A common ramification is that questions on the SFQ may go unanswered, which of course requires additional follow up. Also, it is common for the SFQ to ask for estimations in which case the site is plagued with the question – do I estimate high or low?

Summary & Tips

Not more than 3 years ago, it was common for the SFQ to be distributed through fax blasts. Now, of course, e-mailing Word documents or PDFs are popular options. Still other companies are utilizing web sites such as SurveyMonkey or their own internal distribution and tracking tools. Factors to keep in mind for this process are:

1) Establish effective tactics to pre-identify sites for receipt of the SFQ.

2) Employ efficient methods for the SFQ distribution.

3) Utilize simple, easy-to-use, tracking tools to help monitor SFQ activity.

4) Ideally, data from SFQs received would also be organized and sort-able, to help the study team in the qualification process.

5) This system would also help manage the responses to sites, helping to close the loop on this process.

Most often though, these high-efficiency, automated tools are not in place. The person tasked with this process inevitably will need to be adept at shifting between hard copies, electronic copies, their e-mail software, and some lengthy and cumbersome spreadsheet(s) to track the receipt of SFQs and manually input data obtained from SFQs received.

As is the case with many steps in the clinical trial process – greater transparency and technological advancements can help bring much-needed efficiencies in the process of managing the SFQ.

Allan Valmonte is the Senior Director of Business Development at goBalto and has over 12 years of biopharmaceutical drug development experience. He served as a clinical research consultant for KAI Pharmaceuticals and StemCells, Inc., and held positions in clinical research and development at OXiGENE, Cerexa, and Telik. He has also worked on early, late, and post-approval programs for Integrilin® (Millennium), Vectibix® (Amgen), Lipitor® (Pfizer), and Xolair® (Genentech). Allan holds a B.A. in psychology from California State University, Hayward.

Erik Sam is the Senior Director of Customer Development at goBalto and began his career as an engineer in the Process Research and Development department at Genentech, Inc. There he developed and optimized manufacturing processes in Late Stage Purification for numerous products entering clinical trials. He also ran successful GMP campaigns and collaborations with outside vendors to develop new technologies for the entire biotech industry. Erik holds a B.S. in chemical engineering, with a focus in biotechnology, from the University of California, Berkeley.

Dan Manak is a graduate of the University of Wisconsin – Madison. After earning his bachelor of science degree in Molecular Biology he began his career in pharmaceuticals with Hoffman-La Roche, holding positions in sales, sales management, and training. He has worked in pharmaceuticals, health care, and clinical research for over 20 years with Fortune 100 companies as well as start-ups. For the past seven years he led a small clinical research service organization as the President and Director of Business Development. His expertise and passion exist specifically in the area of clinical study start-up, having worked on several hundred protocols and initiating close to a thousand investigative research sites. In his spare time, Dan is a volunteer EMT and martial artist/Instructor.

About goBalto: goBalto is a small team that creates simple, focused and affordable web based software for the global clinical trial industry. Our products offer drug trial sponsors the easiest possible way to start their clinical studies on the web, which makes them feel better. www.gobalto.com

Veeda Starts 2nd new facility at Ahmedabad

Veeda Clinical Research today started its second facility at Ahmedabad. Spread over 25,000 square feet, the facility will house a bio-analytical laboratory together with an administrative office.



Veeda has plans to expand the clinical facility across two phases which would see the bed capacity rise to around 200. Work on the first phase is likely to be completed by December and would house around 100-120 beds. Further expansion would depend on regulatory approvals, the company said. It, however, did not disclose the investment figures.


The new facility has been designed using GLP and GMP requirements and the laboratory will be capable of housing up to 26 LC/MS/MS machines. Besides, there would be dedicated areas such as high-end sample processing, light sensitive area, special care area where controlled conditions can be maintained for molecule specific requirements. "Additionally, the compartmental lab design will be helpful to maintain confidentiality and cross contamination.This will enhance our capability of handling tricky assays like hormonal, oncology, antiretroviral, endogenous and chiral assays and clinically difficult samples like tissues, patient and infectious samples respectively", Veeda said in a statement, The administrative office will house the finance, human resources, administration, information technology, business development departments as well as key management members. The company now has units in Ahmedabad, UK, Belgium and Germany.


By 2012, analysts project that more than 65 per cent of all FDA regulated trials will take place outside the United States. This is reflected in the Indian biotechnology market, which is expected to grow at a compounded annual growth rate of 30 per cent, and the Indian CRO market, which is expected to see growth of 49 per cent annually.

Source:http://blogs.veedacr.com/Lists/Posts/Post.aspx?ID=350

Clearstone Launches New Website at Central Labs East

New Site Provides Improved Navigation, Biomarker Assay Search Capabilities, and Rich Multimedia Content on the Company’s Recent Partnership with LabCorp Boston, Massachusetts – September 21, 2010 – Clearstone Central Laboratories, a leading provider of central laboratory services for late-stage clinical trials, today announced at the Central Labs East conference the launch of a new corporate website that provides clients with improved navigation, search capabilities, and multimedia content around the company’s extended service offering and recent partnership with LabCorp®.

“Clearstone has been widely recognized as a leader and trusted service provider, committed to long term relationships, operating in an open and transparent way and offering expert, high quality and responsive service to all our clients” said Clearstone CEO Lewis Cameron. “Our new website is just one more example of our recent efforts to engage clients and provide greater information about the exciting developments at Clearstone over the last few months”.

“Clearstone is leading the market in a variety of scientific and operational areas, and we are
pleased to showcase these efforts on our new website” added VP of Business Development Lammert Albers. “There has also been great interest in our recent partnership with LabCorp that provides our clients with access to the largest combined biomarker assay portfolio in the industry, and we encourage sponsors to visit our website or contact their business development representative to learn more”.

About Clearstone
Clearstone Central Laboratories is the largest and most experienced private company exclusively focused on providing central lab services to support late-stage drug development with accurate and timely test data. With over 20 years of experience in mature and emerging markets, we offer world-class laboratory testing, project and data management, and logistical support to leading pharmaceutical and biotech companies around the world. Clearstone’s 500- member global workforce delivers these services from our wholly-owned CAP-accredited laboratories and global kit production facilities in Beijing, Hamburg, Paris, Singapore and Toronto. We also own and operate APOLLO CLPM™ – the leading proprietary central laboratory protocol management system. For more information, visit our website at http://www.clearstonelabs.com/.

Revisiting Partnerships 2010:MCC Clinical Trial Performance Metrics – an industry-Wide Effort

Partnerships in Clinical Trials is taking place this March 30-April 1, 201a in Phoenix, Arizona. Every Friday leading up to the 20th anniversary of the event, we'll be recapping one session from Partnerships in Clinical Trials.

MCC Clinical Trial Performance Metrics – an industry-Wide Effort to Develop and Implement Standardized Performance Metrics

Workshop Presenters:
Cory Gutterman, Assoc Dir, Outsourcing Global Pharma R&D, Abbott Laboratories
Jennifer Holmes, Sourcing Relationship Manager, Global Medical R&D, Eli Lilly & Co.
Mike Minor, VP, Proposals and Business Information, ICON Clinical Research
Guy Mascaro, President, Metrics Champion Consortium

Part I: An Overview of the Metrics Champion Consortium (MCC) Clinical Trial Performance Metrics Initiative

Biotech, Pharma, and Service Providers started this initiative in 2007 in response to growing internal demands for standardized performance metrics around outsourced services, particularly central laboratory metrics. Since inception the initiative has expanded to include metrics for imaging and clinical trials. The beta version of the tool was provided last year during Partnerships 2009, distributed for trial implementation and feedback from participating members.

The metrics themselves are designed to address Clinical Operations, Business Operations, Drug Supply, and Regulatory Compliance. Metrics must be high level and actionable, either leading or lagging as indicators, and benefit both the sponsor and the service provider. There are four types or categories of metrics utilized. These comprise and measure (1) cycle time or time to complete a given task, (2) timeliness or ‘on-time’ measurements, (3) quality, and (4) efficiency or cost. Over 40 metrics exist currently and as processes evolve within the industry it is anticipated that metrics will continue to be developed as appropriate.

One example would be within Clinical Operations where metrics were designed to address the study start-up process. It was felt that ‘study start-up’ being of primary importance to study outcome deserves significant attention. Within ‘start-up’ weighted tools are implemented to review regulatory compliance, dosage formulation and administration, screening, and protocol specific issues including CRF review. Amongst teams that have implemented the beta version of these metrics during the past year the reported study outcomes and tool assessments have been positive.

Ultimately a blinded database, built using a Global Clinical Spotfire Tool Set, is intended to allow sponsors and service providers’ access to the pooled data. For instance, one could query start up times for various world regions, or how many sites in the region have participated in oncology studies, etc. It is possible that service providers would be able access their individual company data to review internal performance across the various metrics. The MCC – CMR International Alliance Partnership board of directors, steering committee, and members are discussing maintaining appropriate confidentiality within a model allowing ‘value-added’ and actionable data analysis.

Part II: Breakout Sessions identified challenges, internal stakeholders, and benefits to implanting metrics within the organization. Some of the issues raised are listed below.

Challenges
-Are the number of metrics, 40, too many? Should a core set be developed?
-Can the business value be defined?
-What is the potential for loss of competitive advantage?
-Is there sufficient time and resource within the organizations participating?
-Are goals appropriately aligned between procurement and operations to allow effective utilization?

Stakeholders

There are corporate, regional, and local stakeholders that need to buy in to the process.

Requires an executive level champion.

Benefits
-Start-up efficiency
- Identification of gaps and issues
- Focused oversight
- Drives sponsor/service provider discussion

Part III Incorporating Performance Metrics in CRO Contracts

The premise to Part III is that the requirement for collection of metrics and the definition of those should be incorporated into the contract, presumably a Master Services Agreement (MSA) helping drive not only operational excellence but feeding back to business excellence and improved risk assessment for both sponsor and CRO. Imperative is the application of standardized metrics to both internal and external process applicable to both sponsor and service provider in order to drive constructive dialogue and performance improvement.

Specific examples are provided in two case studies available in the workshop slide deck. Interestingly, specific agreement on metrics for both sponsor and CRO resulted in improved rejection rates within the CRO whereas the sponsor was unable to achieve the same success on return deliverables. This led to more work for the CRO and improved costs and efficiency for the sponsor.


Posted By: ronald norton

52 Perspectives”An Inside look into Conducting Clinical Trials in Australia”

Partnerships In Clinical Trials 2011 Media Partner goBalto has teamed up with this blog to bring you weekly perspectives on the clinical trials and outsourcing industry. We are very excited to present you with weekly contributions leading up to next year's event!

52 Perspectives”An Inside look into Conducting Clinical Trials in Australia”

Jae Chung

Picture 2This week’s contribution to ’52 Perspectives’ comes to us from John Barlow, the Director of Laboratory Services at Cancer Trials Australia. John Barlow has particular expertise in scientific leadership, strategic planning, and financial and human resource management. His scientific skills include expertise in genetics, clinical chemistry and endocrinology gained during senior executive positions at the Cancer Trials Australia Laboratory, the National Aging Research Institute, the Australian Genome Research Facility, the Alfred Hospital and Monash University.

1. What are some steps your company takes to make the recruitment process go smoothly and successfully?
We go to great lengths to make sure the clinical trial has merit. It is extremely frustrating for us and for the inventor of a new therapy to get together only to find that the pre-clinical work up has not been done adequately, or worse, not been done at all. If the pre-clinical studies have not been done we are happy to provide advice about how to do this and who to consult to go about the process. Only when the appropriate pre-clinical data has been prepared and scrutinized are we confident enough to approach potential first-time-in-man drug recipients.

2. How do you ensure that the subjects in clinical trials have a good general understanding of the research being done to them?
All of our trials are approved by a human research ethics committee and involve the preparation of a patient information and consent form. The HREC will not even consider an application that does not include the PICF written in the patients preferred language and in a form they can understand. Despite this criterion, the PICF can be quite detailed as well as complex and we take the time to make sure patients understand exactly why we are doing the study, what it will involve and what their commitment will be. We also give as much detail as possible about the risks of the treatment and, in the case of cancer clinical trials the expected benefits. Clinical trials for cancer patients are slightly different from trials where the drug recipient is a healthy volunteer. Cancer patients expect to receive a treatment that is at least as good as the standard of care and hopefully they will derive even greater benefit from the regimen being tested.

3. Does the government in your country play a role in educating citizens who participate in clinical trials? How?
Governments at both Federal and State levels in Australia encourage clinical trials firstly by supporting their conduct and making sure that regulatory requirements are established and adhered to. They provide funding for clinical trials centres and at least in the initial phase, provide support for education officers whose role in part, is to ensure the public and potential participants are informed about the community value of clinical trials. They provide a central registry of trials that is publicly available that lists all trials being performed in the country and the relevant details of that trial. And, through maintenance of public and community health centers, they provide infrastructure for the conduct of clinical trials.

4. Give me an example of a public-private partnership between your government and a contract research organization like yourself that really worked.
In Australia almost all clinical trials are a partnership between a government funded organization (the hospital), a CRO (the clinical trials organization), and the sponsor (a private drug company or biotechnology company). The usual chain of events is that the sponsor approaches the CRO who then together develop the protocol for the trial. The protocol is submitted to an HREC (also part of a government health organization) and once approved is conducted by a clinical trials unit within the public or community hospital environment. This process is well established and generally results in a successfully conducted trial but really can only do so because of the common goal of each of the partners.

5. What does your company do in clinical trial documentation and analysis that increases success for new drug approvals?
Our trials are enhanced by the availability of a network of investigators who are linked electronically and thus have ready access to trials progress, recruitment, adverse events and any other episodes that may impact the trial.

6. How is the current economy hurting or helping recruitment?
The GFC has not had an effect either on enrollment or on sponsor interest in clinical trials.

About Cancer Trials Australia:

The CTA Laboratory provides pre-clinical and clinical biomarker assay development services and translational laboratory services to the scientific community. Our services include ELISA, immunohistochemistry, flow cytometry and other immunoassays; nucleic acid extraction and quantitation; blood cell fractionation and storage; and through our partners central laboratory services and genetic analysis.

To contact John, please click here.

About goBalto: goBalto is a small team that creates simple, focused and affordable web based software for the global clinical trial industry. Our products offer drug trial sponsors the easiest possible way to start their clinical studies on the web, which makes them feel better. www.gobalto.com

Do you want to participate in Partnerships in Clinical Trials 2010?

We’re putting the finishing touches on this year’s Partnerships in Clinical Trials! We have a few coveted speaking spots left, and would like to invite you to share your knowledge at our event!

If you would like to speak on any of the following topics below, please contact Partnerships program director Danya Burakoff at dburakoff@iirusa.com. IIR’s 20th Annual Partnerships in Clinical Trials will be taking place this March 30-April 1, 2011 in Phoenix, Arizona. Stay tuned for more information on this year’s exciting program!

• Build Effective Partnerships with your CROs to Succeed in Oncology Clinical Trials and Optimize the Development of Next-Generation Cancer Therapies Workshop
• Technology-Based Solutions and Social Media Strategies for Patient Recruitment, Enrollment, and Retention Workshop
• Advanced Strategies in Request for Proposal (RFP) Excellence Workshop
• Sponsor & CROs Unplugged- Assess the Impact of M&A on Your Outsourcing Strategy
• Streamline Resource Management- How Sponsors Track Resource Utilization in Drug Development
• Reconfigure Payment and Contracting Strategies in Light of Fair Market Value (FMV)
• Achieve Compliance within the Sunshine Legislation Act on your Standardized Disclosure Practices
• Inspection Readiness Strategy in an Era of Heightened Scrutiny of Foreign Clinical Trails- Prepare your company and CRO for FDA inspection, Auditiong, and monitoring the Site
• Site Management Contracting- How to Best Define Responsibilities between Sponsors and CROs to Avoid Accountability Disputes
• Key Legal Considerations in Global Outsourcing- Use Critical Tactics to Create Effective Contracts
• New Technologies for Patient Monitoring in Clinical Trial Subjects

*Please contact Danya Burakoff by Thursday October 21st.

Clinical Trials-India-Need for transparency

Clinical Trials-India-Need for transparency

More than 650 clinical trials are currently taking place in the country and all the leading global pharmaceutical companies such as Astra Zeneca, BMS, Eli Lilly, GlaxoSmithKline, Merck, Novartis, Pfizer and Sanofi Aventis have started moving their key trials to India. India has a large number of patients in 'currently' hot areas for clinical research, like diabetes, cardiovascular disease, HIV and oncology.

It is obvious that the staff at Central Drugs Standard Control Organisation (CDSCO), has a tricky task at hand to bring in transparency and accountability. The global clinical research market is pegged at around $20 billion with India's share being about $485 million. The latter is projected to cross the $1 billion mark by 2015, estimates Frost & Sullivan. Clinical trials are needed and new medicines are imperative, but more than the investment that would come in, the bigger task at hand is to ensure safety of volunteers and generate quality data.

Source: http://blogs.veedacr.com/Lists/Posts/Post.aspx?ID=348

10 Steps to Clinical Study Startup: Step 3 – Sending CDAs to Sites

Partnerships In Clinical Trials 2011 Media Partner goBalto has teamed up with this blog to bring you weekly perspectives on the clinical trials and outsourcing industry. We are very excited to present you with weekly contributions leading up to next year's event!

10 Steps to Clinical Study Startup: Step 3 – Sending CDAs to Sites

Jae Chung

This is the third installment of our ongoing series on 10 steps to Clinical Study Start Up. We hope you enjoy it. And of course feedback/comments/thoughts are welcome!

Introduction

Sponsors and CROs must collect and fully execute Confidentiality Disclosure Agreements (CDAs) with all sites and investigators intended for inclusion in their particular clinical trial. As is the case with any other aspect of a clinical trial, the efficiency by which this step is accomplished can have a significant impact on the timelines and milestones set for the study.

The process varies dependent upon sponsor and CRO standard operating procedures (SOPs). By virtue of the inconsistencies around CDAs, the trial is already at risk for unnecessary delays. Add to that the cumbersome nature of managing the dissemination, completion, and collection of CDAs for all sites/Investigators, this simple and crucial document can be held accountable for noteworthy study startup delays.

There are a wide variety of reasons that could lead to delays in this step. One reason for a delay could be that the site wants to negotiate terms of the CDA, which involves the legal department of the sponsor &/or CRO, and several days, if not weeks, can go by before an agreement is reached. Other possible delays could be due to shipping mishaps or multiple parties requiring multiple CDAs (Sub-I’s, site, and PI).

How CDAs are currently sent and tracked

Currently, the Sponsor/CRO needs to send the CDA to each site through email, fax, or mail. After circulating the document back and forth with the sites and obtaining the appropriate signatures, moving to the next step may involve the sponsor/CRO “batching” the signed CDAs. This means that the partially executed CDAs will be taken for full execution at a set time (e.g. every Friday). This is followed by the next step (e.g. sending the protocol) in a similar ‘batch’ fashion. Alternatively, the CDAs may be handled in a piece-meal fashion, where each site moves on to the next step as soon as their returned CDA is received.

This all has to be done on a set time-line, otherwise investigator recruitment can begin falling behind schedule, thus delaying site initiations, first patient enrolled, and database lock. In many companies, this is an extremely manual and labor intensive process, requiring much followup on the part of the sponsor/CRO to assure timeliness and accuracy.

Some key tips for the sponsor/CRO as well as the site are:

To ensure efficiency with CDA process, the sponsor/CRO should communicate their needs early and clearly with the sites.

1. Does the CDA need to be executed prior to the receipt of the study questionnaire synopsis?
2. Does the execution of the CDA only preceed the sharing of the protocol, following the first wave of feasibility questionnaires?
3. How will the site/PI specific information be incorporated into the CDA?
4. Who is/are the party(ies) with whom CDAs will be required? (Some require the site to sign, others the PI, and still others will require both, including any sub-Is.)
5. Will the sponsor or CRO send an editable version in Word, or do they want just the pertinent information from the site, so that they may customize the document?
6. Will the sponsor/CRO accept a scanned version of the signed CDA to expedite the process of moving on to the next step?

A system should be in place for the sponsor/CRO to:

1. Create and disseminate CDAs en masse to sites and investigators
2. Track receipt of signed CDAs
3. Generate internal and external alerts when time lines are not met
4. Internally manage site requests for custom CDA’s with efficiency
5. Incorporate in the SOPs the acceptance of an electronic version to move on to the next step in the process, reducing the impact of this process by several days to a week.

Sites should have processes in place for the management of CDAs, including the receipt, review, execution, return, and internal filing of the CDA. Communication by the site should also be transparent. For example; if the PI is required to sign and currently on a vacation, will it be acceptable to wait, or will it be required to track the PI down and obtain a signature ASAP?

The timeline in this process for a site should not exceed 48 hours.

Conclusion

This is an expected and standard process within all clinical trials. Open and clear communication by all parties as well as sound, professional processes in place will assure the efficient completion of this step, usually within 48 hours.

About the Authors:

Allan Valmonte is the Senior Director of Business Development at goBalto and has over 12 years of biopharmaceutical drug development experience. He served as a clinical research consultant for KAI Pharmaceuticals and StemCells, Inc., and held positions in clinical research and development at OXiGENE, Cerexa, and Telik. He has also worked on early, late, and post-approval programs for Integrilin® (Millennium), Vectibix® (Amgen), Lipitor® (Pfizer), and Xolair® (Genentech). Allan holds a B.A. in psychology from California State University, Hayward.

Erik Sam is the Senior Director of Customer Development at goBalto and began his career as an engineer in the Process Research and Development department at Genentech, Inc. There he developed and optimized manufacturing processes in Late Stage Purification for numerous products entering clinical trials. He also ran successful GMP campaigns and collaborations with outside vendors to develop new technologies for the entire biotech industry. Erik holds a B.S. in chemical engineering, with a focus in biotechnology, from the University of California, Berkeley.

Dan Manak is a graduate of the University of Wisconsin – Madison. After earning his bachelor of science degree in Molecular Biology he began his career in pharmaceuticals with Hoffman-La Roche, holding positions in sales, sales management, and training. He has worked in pharmaceuticals, health care, and clinical research for over 20 years with Fortune 100 companies as well as start-ups. For the past seven years he led a small clinical research service organization as the President and Director of Business Development. His expertise and passion exist specifically in the area of clinical study start-up, having worked on several hundred protocols and initiating close to a thousand investigative research sites. In his spare time, Dan is a volunteer EMT and martial artist/Instructor.

About goBalto: goBalto is a small team that creates simple, focused and affordable web based software for the global clinical trial industry. Our products offer drug trial sponsors the easiest possible way to start their clinical studies on the web, which makes them feel better. www.gobalto.com

The Partnerships Team: Danya Burakoff, Conference Director

As the 20th Partnerships in Clinical Trials approaches next April, we wanted to you get to know the staff behind the event. Every two weeks, a Partnerships Team Member will share some of their memories and experiences with the event. Today, we have Danya Burakoff, the Conference Director of this year's event.

1) What do you do for Partnerships in Clinical Trials? How long have you been working on the Partnerships Event?
I am the new program director for Partnerships in Clinical Trial and I am very excited to join the team for our 20th anniversary celebration!

2) What has been your favorite part of taking over Partnerships in Clinical Trials?
I have enjoyed delving into the content development for the 2011 program in order to bring forth more advanced sessions as well as many new topics for the meeting. I am working closely with speakers to develop innovative interactive formats for our conference sessions. I am also excited for some of the "surprises" we are developing for our 20th Anniversary celebration, and for building a more active and engaged Partnerships community.

3) Which speaker are you looking forward to hearing from this year?
There are many speakers I am looking forward to hearing from, especially those who will address some our new topics for 2011- such as: The Emerging Markets Jeopardy, a Fast Money Showdown, the Stakeholders Debate on Operational And Longer Term Strategies for Profitability and Growth in Global Clinical Trials, and our keynote sessions on Executing the Challenge of Innovation- Vijay Govindarajan and Change Management- Dan Heath. I am also excited about our Industry Future C-suite Fireside Chat.


4) What's your favorite food? I love Greek food and anything spicy...For my sweet tooth, I like dark chocolate.

5) What are you looking forward to the most for our 20th Anniversary? Meeting all the speakers, attendees, and sponsors that I have been corresponding with throughout the year in person and welcoming new speakers and attendees to the Partnership family.

Partnerships Poll: As outsourcing continues to grow, in what way do you expect regulatory oversight to change the most?

We want to make the Partnerships in Clinical Trials an interactive online network for you! This week on the Partnerships network, we have monthly polls for you to participate in. You can vote by visiting any of these sites in the Partnerships network: Partnerships in Clinical Trials blog, @PartnershipCROs Twitter, and our Partnerships with CROs LinkedIn group.

The future of Global Pharma

The future of Global Pharma



The global drug market will grow to 5 to 7 percent in 2011, to $880 billion, as higher spending in nations like China, Brazil and India makes up for slow growth and patent losses in the United States, according to a forecast released Wednesday by IMS Health, an industry data company. Prescription drug sales in 17 countries are growing at a 15 to 17 percent clip, led by China. It alone is expected to have sales growing at a rate of 25 to 27 percent to $50 billion next year, IMS Health said. Next year, patents expire on the two top-selling drugs in the world: Lipitor, the cholesterol drug from Pfizer, which had $13.2 billion in sales last year, and Plavix, the blood thinner from Bristol-Myers Squibb and Sanofi-Aventis, which had $9.1 billion in sales. Mr. Aitken said the full effect of lower-priced generic competition would be felt in 2012.

http://blogs.veedacr.com/Lists/Posts/Post.aspx?ID=345

Could there be a global frame work for clinical trials?

The European Medicines Agency has suggested there should be a global framework for clinical trials. They pointed out that only 38.8% of all participants in clinical trials in the UK, the remainder of the participants are located throughout the world, as reported by Pharma Tech.

Thomas Lönngren, Executive Director of the EMA, said:
“What is needed is a robust framework for the oversight and conduct of clinical trials, no matter where in the world the clinical investigator’s sites are located and patients recruited. The Agency is committed to build and extend its relationship with regulators in all parts of the world and with international organisations to work to standards agreed and recognised by all.”

52 Perspectives: “Accelerating Patient Enrollment for Clinical Trials”

Partnerships In Clinical Trials 2011 Media Partner goBalto has teamed up with this blog to bring you weekly perspectives on the clinical trials and outsourcing industry. We are very excited to present you with weekly contributions leading up to next year's event!

52 Perspectives: “Accelerating Patient Enrollment for Clinical Trials”

Jae Chung

This week’s contribution to ’52 Perspectives’ comes to us from Vatche Bartekian, the President of Vantage BioTrials Inc. Vatche founded Vantage BioTrials Inc in April, 2007. Prior to taking on this new venture, he was an independent clinical research consultant working mostly for big pharma. He has been involved in the pharmaceutical industry for over 10 years and has gained broad experience handling complicated clinical trials across a vast array of therapeutic areas, specializing in clinical operations, project management and clinical monitoring.

1. What are some steps your company takes to make the clinical trial process go smoothly and successfully?

At Vantage BioTrials, our experience has shown that the best way to ensure a smooth and relatively successful process along our clinical trial management activities is by first developing a clear plan of communication between ourselves and the Sponsor.

Our Communication Plans are put into drafting as soon as the service contract has been signed. They are further finalized once Project Kick-off Meetings are held and logistics are agreed upon for the management of the study. The key players (i.e. decision makers) for the study are identified early, and we do our best to never change the team throughout the life of the project, unless otherwise requested by our Sponsor. This type of team continuity plays another important role in the success of the study. This is also why we work very diligently to maximize employee retention and minimize turnover at the project level.

Finally, we ensure that tools are set in place to aid the tracking of progress for the project and these tools are kept as simple and user-friendly as possible. Redundancy and duplication of efforts or information is usually a major factor in unnecessary delays throughout the lifecycle of a project, and our metrics tools have greatly helped in minimizing these delays.

2. What range of service and product offerings does your company have to ensure quick patient enrollment and reliable data?

Depending on the type of project (phase I through phase IV), we use a multitude of patient enrollment tools and services:

a) We partner with local or international service providers specialized in Patient Recruitment services who have demonstrated a strong track record in past studies.
b) We use social media tools (such as facebook, twitter, linkedin, etc) to advertise clinical study information and set-up a single hotline for interested participants to call.
c) We advertise the study on clinical study database sites such as Clintrials.gov, clinicaltrials.gov, NIH website, CentreWatch.com, EudraCT, ClinicalConnection.com, etc
d) We use Territory Development strategies to reach out to potential clinical investigative sites in a given region who might be interested in the investigational product.
e) We invest a lot of effort to improve communication and cooperation between Sponsors, academic research networks and investigative trial sites to maximize patient enrollment.

3. What are the major challenges to delivering high quality data in a clinical trial?

Although challenges abound in running clinical trials in general, the US Food & Drug Administration often cites deficiencies in record keeping during almost every inspection they perform. Without a proper paper trail and sound documents that capture relevant data for analysis to determine the safety/efficacy of any study medication, the quality of the data comes into question.

When creating a development plan for clinical trials, a lot of consideration has to be put into the end product, mainly, the information needed for the package insert/marketing application. The development plan must, therefore, be attacked from the other end (i.e. backwards) to meet study goals. It becomes necessary to consider what the protocol and CRFs must look like in order to achieve quality data to support the marketing application.

When developing CRFs, this should be done as a team approach, enabling input from all sides and individuals (including clinical staff, medical advisors, data management, quality assurance and regulatory affairs).

Patient compliance is also a big factor in obtaining usable quality data. Any non-compliance impacts the required sample size, hence possibly delaying the study, increasing the overall costs associated with trial management, and also decreasing the level of quality data. In order to avoid patient non-compliance issues, the following strategies can be implemented early on: reminders, newsletters, comfortable clinic visits, education, a simple ICF document (which essentially becomes the patient’s contract with the sponsor and the site), introducing a graduated regimen for more complex studies, enlisting family/friend support, and rewarding the patient’s compliance.

4. How does your company access deals and new contracts with increasing competition from the growth of the CRO industry in emerging markets?

As a Canadian-based CRO with operations mainly spanning North America, Vantage BioTrials has strategically aligned itself with partners in Latin America and Europe to provide our clients with the same high-quality services in those regions. Through collaboration with our partners, we are able to tap into regional expertise and align our standard operating procedures while maintaining the same high level of quality that the Canadian clinical research arena is known for.

Although it is almost impossible to directly compete with the low-cost offerings in emerging clinical research markets globally, we do strongly compete on the quality side of the R&D landscape. We are slowly noticing a shift back to North America from sponsors who had previously placed their R&D efforts in these emerging markets as they’ve realized that, although the short-term expenditure savings add up, the long-term cost of a trial increases as studies need to be repeated or delayed due to serious concerns of quality and integrity of data.

The key factor for accessing more deals and keeping studies in North America is to continue to improve quality, be more flexible with cost, and collaborate with all levels of industry (academic, government, client, service provider and investigative sites) to identify process efficiencies and increase recruitment speed while enrolling good-quality patients.

5. How is the current economy hurting or helping recruitment?

Ever since the economic downturn began in 2008, we believe it has had, unexpectedly, a positive increase in the number or ease of patient recruitment into clinical trials in North America. Due to lack of steady income and financial hardship for many average citizens, they are forced to “think outside the box” and consider volunteering for clinical trials that pay (for early-phase, or BE/PK/PD studies, etc) or participate in later-phase trials that cover the costs of all medical expenses. It would be very interesting to see an industry-wide survey performed regarding this issue to factually gauge the numbers.

About Vantage BioTrials:

With headquarters in Montreal, Canada, Vantage BioTrials Inc. is a Clinical Research Organization that provides superior trial management services and combines a precise blend of clinical development knowledge, talent and resources that will ensure your clinical studies full potential. We possess highly seasoned professionals, averaging 10 years experience. We also cover a vast geographical area by offering our services in North America, Latin America, and Europe.

To contact Vatche please Click Here

About goBalto: goBalto is a small team that creates simple, focused and affordable web based software for the global clinical trial industry. Our products offer drug trial sponsors the easiest possible way to start their clinical studies on the web, which makes them feel better. www.gobalto.com

Partnerships Poll: As outsourcing continues to grow, in what way do you expect regulatory oversight to change the most?

We want to make the Partnerships in Clinical Trials an interactive online network for you! This week on the Partnerships network, we have monthly polls for you to participate in. You can vote by visiting any of these sites in the Partnerships network: Partnerships in Clinical Trials blog, @PartnershipCROs Twitter, and our Partnerships with CROs LinkedIn group.

Collaborations as a home grown business model

Collaborations as a home grown business model

This is one of the models which many global Pharma companies are eyeing in the current competitive scenario. One of the major countries eyeing the Indian geography today is Japan. Top Japanese drug makers are planning big presence and investments in India, within two years of India’s largest manufacturer, Ranbaxy Laboratories, being taken over by Daiichi Sankyo, the third largest Japanese one. Last week, the $40-billion Mitsui & Co Ltd announced it would acquire a five per cent stake in pharmaceuticals ingredient manufacturer Arch Pharmalabs for `65 crore. The move is to strengthen its contract manufacturing business in the pharmaceutical sector. Mitsui has had a business relationship with Arch for the past four years. The strategic stake sale will help the 1,200-crore Arch to foray into supply of active ingredients and intermediates in the tough Japanese market, as Mitsui will exclusively market Arch’s products in Japan.


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