Friday, September 30, 2016

Can Big Data Cure Cancer?

"The release of public data is the next big world in the clinical trials space and neutral third parties who are not part of the trial are going to innovate using our trials data." Atul Butte MD, PhD, Director of the Institute of Computational Health Sciences, University of California, San Francisco (UCSF)

The release of public data is the future of clinical trials. With about 50% of clinical trials failing, outside of summaries on, the raw data is never distributed for review. And what would this mean for the industry? It means that more questioning and review would happen, truly getting to the bottom of why a trial failed or succeeded. These third party researchers will be able to draw conclusions, like for instance "that the drug is working in a subset of patients", then that discovery will be present in trials moving forward - thus innovating the field.

Find out all the good that Atul feels proper data management and review will have for the industry in this exclusive interview.

Thursday, September 29, 2016

Rare Disease Research: It Pays to Engage

Michael Christel, Pharmaceutical Executive

Behind the momentum of precision medicine programs such as Cancer Moonshot, coupled with the overall shift taking place toward ultra-targeted treatments—gene therapy, immunotherapy, biologics—the rare disease space seems to be joining the rarefied air of more common disease segments in biopharma business pursuits.

After all, by 2020, the rare and orphan drug market is forecast to grab 20.2% of worldwide prescription drug sales (excluding generics) and total $178 billion in annual revenue. In the US, the FDA granted nearly double the number of orphan drug designations in 2015 compared to 2010. The demographics are well documented: rare diseases affect fewer than 200,000 patients, but, in aggregate, afflict as many as 350 million people worldwide—more than the total for cancer and AIDS combined. Children are especially impacted; about 35% of deaths in the first year of life are reportedly caused by these conditions.

But despite greater financial and regulatory incentives to develop drugs for rare diseases, plenty of caution remains. The low prevalence of these conditions still results in various challenges in development, pricing, and reimbursement. And with treatments usually requiring large per-patient payments, this area won’t be immune to the pricing scrutiny that continues to swarm the industry.

Juliet Moritz, executive director of strategic development in rare diseases for Premier Research, a CRO, has watched all these trends unfold with a close eye. Involved in clinical research for 28 years, with experience in single-site studies as well as large, multinational trials, Moritz is particularly passionate about informed consent and the role of patient advocacy involvement in clinical research and its impact on the regulatory process.

To get the pulse of rare disease research at the moment, Pharm Exec recently chatted with Moritz, where she discussed the challenges and opportunities unique to this specialty market—particularly related to growing focus areas such as patient engagement.

Wednesday, September 28, 2016

Why use home care visits in clinical trials?

by Dr Bettina Bergtholdt, Managing partner at Emovis

Study participation can cause significant burden for patients: the frequency of requested clinic visits is usually high, the time spent at the study site can exceed many hours until all requested data are collected and not to forget the sheer travel time. Even in studies with a patient population suffering from mild diseases, the time consuming aspect of study participation keeps many eligible patients off from taking part in studies.

Recruitment rates and drop-out rates are even more affected by the burden of study participation in the following groups of patients:
  • - Severely ill patients, particularly those with a life-threatening or disabling diagnosis, as clinic visits might become more difficult
  • - Rare diseases, if distances between study site and home of patients are quite far
To avoid low recruitment rates or high drop-out rates in such studies, the concept of home care visits in clinical studies is becoming more and more popular over the last years.

Tuesday, September 27, 2016

The Need for Patient-Centric Payments in Clinical Trials

by Shree Kalluri
Patient recruitment for clinical trials

The traditional process of paying stipends and reimbursements to participants is still a prevalent issue in clinical trials. This payment process has typically followed an outdated, manual model that rarely takes into account a patient’s lifestyle and personal preferences. Today, some of the most common or traditional payment methods used in clinical studies are often the least patient-centric.

In many clinical trials, participants are only provided with a single payment option, often in the form of a check. Patients can be left waiting anywhere from four to eight weeks before receiving a single payment. This is especially inconvenient, as many patients have to personally pay upfront, out-of-pocket expenses to get to the site. Additional expenses could also include lodging, childcare, meals and the cost of time missed from work. With this prolonged and slow payment model, participants could be on their next study visit before ever receiving payment from their previous visit.

Monday, September 26, 2016

The Power of Predictive Analytics For Life Sciences

Today’s guest post comes from David Lee, chief data officer at Medidata Solutions. Don’t miss his presentation at PCT US on October 6 on predictive modeling.

Predictive modeling for life sciences

The confluence of new data sources and new predictive modeling methods is revolutionizing clinical trials and the development of experimental therapies. Predictive modeling can play an essential role in three fundamental aspects of clinical trials: improving data quality, increasing operational efficiency, and including data from new sources.

Data quality

We’ve all heard the saying, “Garbage in, garbage out.” Data quality – accuracy and completeness – is vital to the scientific return on the investment in clinical trials. Inaccurate data arise frequently from a variety of sources, including entry errors, insufficient training, subjective differences and even site misconduct. Predictive models can be utilized to identify anomalies in clinical data in near real time; these can then be systematically corrected, well before database lock. Further, automated error detection can alert sponsors to data problems, whether or not these are expected. Sponsors, CROs, and regulators alike will benefit from this new paradigm in data quality, which is improving the quality of clinical data and the resulting scientific findings.

Friday, September 23, 2016

Stupid Cancer Founder Matthew Zachary's Story

After surviving brain cancer as a 21-year-old, Matthew Zachary founded Stupid Cancer in 2007 to address the 72,000 new diagnoses of young adult cancer each year. It has since grown in to the largest US charity providing advocacy, research and support for the often neglected group of 15 - 39-year-olds.

We spoke to the self-described ‘global healthcare disruptor and Chief Angry Officer’ about his story and how patients are treated.

Matthew is speaking at Partnerships in Clinical Trials Europe in Vienna on 16 November 2016. Join over 1000 clinical trials industry leaders at the two day event - find out more here

Thursday, September 22, 2016

7 Predictions for the Future of Clinical Trials

Over the past six months we’ve spoken to dozens of industry leaders and asked for their predictions for the future of the clinical trials industry over the next 2-3 years. We’ve gathered 7 of the most common answers below…

1) Partnerships will develop

“The industry will be leaner. We will still need to work at building good outsourcing partnerships.” Mireille Zerola , Risk Based Monitoring Implementation Project Lead, Boehringer Ingelheim

“Today’s fledgling strategic partnerships will have matured, allowing sponsors and CROs to better realize their potentials.” David Shalhevet, Associate Director, Senior Clinical Trial Manager, Teva Pharmaceutical

“I hope we will be really seeing the benefit coming out of the industry consortia, such as TransCelerate, where different companies work together for the benefit of the patient.” Diane Driver, Head Outsourcing Contracts & Strategic Partnerships, UCB

Wednesday, September 21, 2016

Third-party vendor oversight – how much should sponsors delegate to CROs?

In the strictly regulated business of developing new medicines, medical procedures and devices, when it comes to the management of third-party vendors, the question of where the buck stops has never been so complicated.

Ultimately, the pharmaceutical company sponsoring the research must take full responsibility for all their trials, but many sponsors are now outsourcing the monitoring of the clinical trial to specialised contract research organisations (CROs), and then in turn outsourcing certain parts of the work to third-party vendors or sub-contractors. This makes the question of who is responsible for ensuring that Good Clinical Practices (GCP) are adhered to a hotly-debated issue.

GCP regulations ensure both the protection of patients and credibility of data, so oversight must be maintained to protect the sponsor’s interests and ensure the delivery of a successful clinical trial – on time and on budget.

Tuesday, September 20, 2016

Designing for better trial recruitment

Despite some improvement, many organisations still have difficulty committing to recruitment targets and we need to find out why. Research by organisations like Tufts University shows nearly half of all sites fail to enrol a single patient and that, on average, recruitment takes twice as long to achieve as expected.

But while these finding illustrate the scale of the patient recruitment problem, they don’t explain why we as an industry face this challenge and it is important that sponsors and CROs consider what factors may impact recruitment.

Monday, September 19, 2016

How Open Communication with Clinical Research Sites Will Improve Study Operations

by April Schultz, Content Marketing Writer, Forte Research Systems

Open Communication with Clinical Research Sites Can Improve Study Operations

Communication among stakeholders in the clinical research industry is integral to the success and improvement of clinical trial conduct. Though the industry continues to adopt new forms of technology to enhance communication between sites, sponsors, patients and more, many industry relationships are still hindered by miscommunication.

In particular, the relationship between sponsors and clinical research sites has historically been strained due to a consistent struggle to effectively communicate. With both parties juggling numerous studies and tasks at any given time, it’s difficult to address concerns in a timely manner and miscommunication is likely. The addition of a CRO extends the chain of communication between sponsors and sites, potentially exaggerating the struggle to relay information to appropriate individuals.

To alleviate this struggle, it’s important that both sites and sponsors actively maintain an open line of communication. One way sponsors can promote open communication is to encourage feedback from sites throughout the course of a study and after study closeout.

Friday, September 16, 2016

Weave New Technology into Clinical Development

"One of the things I'm most excited about is the use of technology. The thing I am also most concerned about, is the use of technology."

Cathy Dawson, Director of Clinical Affairs at Aesclup sat down with the Partnerships in Clinical Trials team for this exclusive interview. Watch the interview above as Cathy discusses; driving collaboration, clinical quality systems, building an internal clinical quality system compliant with FDA regulations, clinical trials for medical devices, clinical trial data, and eClinical technologies.

In this interview, Cathy explores what drives collaboration through a CRO partnership. She say's, "When I think about driving collaboration through the CRO partnership, I am thinking about my end customer; not just the surgeon, the hospital, or the study nurse - I'm also thinking about the patient. So when I'm thinking about partnering with a CRO and driving collaboration, its with those folks in mind.".  She continues on to talk about how it is imperative there is a 'value add' for all parties involved in the process, closing out by saying, "Who is the end user? Who is our customer? and it's not just me as the Sponsor/industry; it's the caregiver and it's the patient ultimately."

Check out the complete interview now to hear all of the insight Cathy has to offer on these exciting topics.

Thursday, September 15, 2016

Reality Check on Data Convergence

by Michael Christel, Pharmaceutical Executive

Most will likely agree that the data explosion taking place in clinical research today has moved well beyond trend status. It’s very real; industry attention in this area—as a legitimate force for change—is building considerably. And the focus is wide-ranging: big data, eSource, real-world data, electronic health records, wearables, advanced analytics, remote patient monitoring—and on and on.

These are indeed exciting times to dream big on how these new data technologies and process improvements can potentially revolutionize clinical trials. But before we get too caught up in the grandeur of what could be, a prudent lens on things is also warranted. R&D experts and clinical research professionals are often quick to point out that one of the biggest issues in managing this data convergence in the life sciences is connecting reality with the conceptual promise of these “next-generation” information tools and processes.

“Like so many industries, the drug development enterprise tends to approach the use of technologies with this tremendous exuberance that is so far removed from the realities,” says Ken Getz, the longtime chairman of CISCRP and director of sponsored research at the Tufts Center for the Study of Drug Development. “This exuberance comes without really thinking through the kind of long and painful journey that’s going to be required by all of the workforce within drug development to change legacy processes and systems. Some of that will require cultural change and philosophical change in how we approach development activities.”

Here are more excerpts from Pharm Exec’s recent conversation with Getz, where he discussed the steps and mindset necessary to truly harness data to improve the research process of tomorrow.

Wednesday, September 14, 2016

What Is Patient-Centricity?

By Norman M. Goldfarb

Most clinical research professionals would probably agree that patient-centricity is very important, but we lack a common understanding of the term. This article will propose a definition for patient-centricity and identify characteristics that make a clinical study patient-centric.

Defining “Patient-Centricity”
The first principle in defining patient-centricity is that the term itself should be patient-centric. In other words, when patients read the definition, they should agree with it from their perspective. Patient-centricity is not about our goal of recruiting more patients for clinical studies — it’s about their goals when they participate in a clinical study. It is not about our methods for communicating information to patients — it’s about their preferences for obtaining information.

Since different patients have different goals, concerns and preferences, the second principle of patient-centricity is that it must be specific to each individual patient, or at least each group of patients with like characteristics. Patient-centric studies provide a personalized experience for each study participant. The third principle of patient-centricity is that it begins when a study is contemplated and ends when the patient’s experience is complete.

Clinical trials and IoT: How mHealth, wearables and the Internet of Things will create the clinical trials of the future

by Sarah Iqbal

The Internet of Things is increasingly a topic of conversation in the world of technology. To define it in very simple terms, IoT is a network of devices. This network connects any device, machine or sensor to the internet. Gartner forecasted that there will be 25 billion connected devices by 2020. So, it can be said that the IoT is a giant network of connected ‘things’, which indirectly includes connecting people because people use these ‘things’.  As Jacob Morgan puts it in Forbes, this relationship will be between people-people, people-things, and things-things. The way all these devices work together is made possible by the fact that almost all of us now have access to the internet and a smartphone.

The birth of IoT was enabled by the internet, and more specifically broadband internet. Broadband internet is becoming more widely available and more devices (and now wearables) are created with Wi-Fi capabilities and various sensors built into them. In addition, smartphone penetration is increasing. More and more people rely on their smartphone (and other smart devices) to get online and go through their daily, even menial, tasks. In 2016, the number of smartphone users is forecast to reach 2.08 billion. By 2019, the number of mobile phone users in the world is expected to pass the 5 billion mark. These factors create the perfect environment for IoT, driven by the need of consumers to constantly be online.

Monday, September 12, 2016

Patient Engagement: The Key to Repeat Participants and Patient Referrals

Patient recruitment for clinical trials

By, April Schultz, Content Marketing Writer, Forte Research Systems

Patient recruitment has been a constant pain point for the clinical research industry. The struggle to find individuals to actively participate on a study often halts the progress of getting potentially game-changing treatments to those that need them. Many articles suggest ways to spread the word about clinical research to those unfamiliar with the concept and increase awareness for clinical research to the general public. However, these articles often fail to mention one key population: repeat study participants.

While not applicable for every study, repeat participants are many times the most valuable part of a researcher’s participant database. These individuals can be considered experts of clinical trial participation, as they understand the value of clinical research, they are familiar with what is required of them during the course of a study, and are therefore more likely to finish the entire clinical trial. Efforts to actively engage clinical trial participants could increase the number of repeat study participants and potentially generate more awareness for clinical research.

Friday, September 9, 2016

Collaborative Methodology for Risk Based Monitoring of Clinical Trials

Even though a lot the context from a technology/process standpoint has changed over time. The real guts of what we do has essentially been the same for several decades, if you think about clinical data management being about acquiring data initially from sites, running that through a series of central checks to check if its valid and questioning back to the site if it’s not, and finally turning the data package over to someone downstream (like a statistician) to make a decision. That essentially hasn’t changed over several decades and increasingly that process is just not good enough for what we demand of clinical research. Whether it’s the speed we need to make decisions or the initial quality and burden of getting to the quality places on the sites.

“The biggest challenge and opportunity in my current role is to reimagine what clinical data management really is” 

In this exclusive interview, Gary Thompson, Senior Director of Data Sciences, Eli Lilly & Co. sat down the Partnerships in Clinical Trials US team to discuss the biggest challenges and opportunities in clinical data management, risk based monitoring and more. 

Thursday, September 8, 2016

Strategic Partnerships in Clinical Trials [Whitepaper]

Are Strategic Partnerships in Clinical Trials Living Up to What They Promised in Terms of Cost, Efficiency and Service Quality?

Whitepaper Overview:

The journey of a drug or device from its birth to the time it reaches the patient is long and arduous. The longest and most expensive part of the journey is during drug development and clinical trials. Only 5 percent of drugs being developed actually make it to the market. Traditionally clinical trials were conducted in-house by the pharmaceutical companies. They employed full time personnel for conducting trials. Over time, the process of conducting clinical trials has become increasingly complex due to multi-center recruitment, involvement of clinical investigators in several centers, new regulatory guidelines and shift in demographics of trials from usage heavy countries like USA to clinical trial naïve patients in Africa and Asia. Concomitantly pharmaceutical companies under pressure to reduce staffing costs with smaller budgets to conduct clinical trials are outsourcing their drug development to contract research organizations who are help conduct clinical trials at a lower cost. This has lead to a trend of an entire smorgasbord of partnerships from tactical to strategic between pharmaceutical and biotech sponsors and CROs.

In the last decade between 70 -90 % of the sponsors have entered into a partnership with a CRO. According to a Quintiles study, partnerships range from tactical (“fee for service”) to preferred (“reduced price fee for service”) to partnering (“risk sharing and shared milestones”) to alliances (“sharing both profits and risk”) to integration (with maximal closeness and mutually beneficial relationship). In practice, partnerships are a mix of both tactical and strategic components depending upon the needs of the Sponsors and the CROs.

Success is ideally assured when both partners work together to achieve their common objective as well as assist each other to achieve their individual objectives. However, most partnerships are neither ideal nor completely successful. Similarly Sponsor –CRO partnerships are fraught by failure to align partner expectations and goals, failure to communicate adequately leading to delayed clinical trials and subsequently greater costs.

Today every field of medicine is highly specialized e.g. otologists, rhinologists, cardiologists, pulmonologists etc. Similarly Sponsors and CROs too are highly specialized and can offer their individual expertise to the field of drug /device development. The rocky road of strategic partnerships can be smoother if both partners were to work as a team to develop valuable drugs to alleviate diseases.

Veterans in the biopharmaceutical –CRO market place have a few pearls of wisdom for successful Sponsor – CRO partnerships:

  • Align mutual expectations
  • Develop a common direction for the partnership
  • Develop mutual respect for each other
  • Improve communication. Avoid postponing discussion and problem solving
  • Learn from each other’s mistakes instead of finger pointing
  • Prepare management manuals to preserve and perpetuate best practices
  • Foster long term relationships which enable CROs to offer volume discounts and consistent rates

Wednesday, September 7, 2016

Is the virtual CRO the future of clinical trials?

Join Alexander Gissler on Wednesday 21st September, 2pm BST

Alexander Gissler is CEO of ProjectPharm - a niche CRO providing project management services. On Wednesday 21st September, he is running a webinar on virtual CROs and other future outsourcing models. Here he introduces the topics and explains what to expect on the free webinar:  

"The virtual CRO is a new model of partnership between sponsors and contract research organisations. It is an advantageous blend of the strategic partnerships that have been on the rise between big players during the last few years, and the older model of requesting RFPs to a selection of CROs for each individual project to be outsourced.

The virtual CRO model allows sponsors to use a global workforce with no resource restrictions (which is the aim of the strategic partnerships), whilst at the same time keeping the prices at a significantly lower level than what is possible for big CROs (which is the aim of outsourcing each individual project separately).

Tuesday, September 6, 2016

Uncertainty: Vital for Innovation

Uncertainty is Vital for Innovation in Pharma and Biotech

We all know people who are certain: certain of the way things should be done, certain of the outcome and certain of the future. We hear it from politicians all the time.

Yet, in business, the critical ingredient of innovation is uncertainty. Innovation, by definition, is creating something new. At the beginning, there will be lots of questions that can’t be answered. So how do you help a team move forward into uncertainty? Last month at the Aspen Institute in Colorado, I was among a group of ambitious female entrepreneurs to hear from Dr. Pamela Paresky on the power of valuing the unknown. As she said, in a world of uncertainty, leadership matters. And when you’re uncertain, you notice more.

Businesses are usually built on waves of innovation. First comes the initial idea on which the business is built. It may be a price difference from your competition, a new way of delivery, or a new segment of a growing market. But that first idea won’t be enough. To stay ahead of the competition, a business will have to continue to innovate. In the Alchemy of Growth, Mehrdad Baghai talked about three necessary horizons of innovation.

Some of your team will need to stay focused on delivering that first core business. Others will need to be thinking about the horizons to come.

Uncertainty is uncomfortable, so it’s important to seed your business with the thought that failure in innovation is OK. It’s more than OK: it’s what is required so long as failure is fast and the team is able to move on with the lessons learned. Here is what I’ve learned from experience:

Monday, September 5, 2016

Managing Mutual Expectations – Persistent Challenges in a Mature Industry

Since the emergence of the first contract research organizations (CROs) 35 years ago, outsourcing has become an integral and indispensible aspect of clinical development. The contract research industry is considered mature. Best practices for cooperation have been developed on both sides of the Sponsor–CRO interface. Many Sponsor companies have dedicated CRO management departments, and most CROs have dedicated client relationship managers. Against this background, you would not expect too many surprises at the interface during a Sponsor-CRO collaboration. 

Nevertheless, when I ask Sponsor representatives to rate their experience of working with CROs as positive or challenging, the most frequent reply is “it depends”. The factors underlying this perception vary widely. “It depends on the CRO company” may not sound unreasonable. However, even when working with the same CRO, and despite the considerable efforts towards harmonization and standardization over the last 35 years, the level of Sponsor satisfaction still appears to depend on factors such as individual CRO project team members, the location of the CRO affiliate office, or the nature of the services outsourced. Many Sponsor employees have come to accept outsourcing as an inevitable fact of their working lives, while their enthusiasm for working with CROs remains muted. Most likely, on the other side of the interface, CRO employees have similar thoughts.

Friday, September 2, 2016

The Challenges of Clinical Trials in Surgery with Professor Iain Hutchison

“You can stop a drug if it’s causing problems, but you can’t stop an operation. The problem with clinical trials in surgery is that it is a decisive, irreversible act. Surgeons aren’t natural clinical researchers, but all that is changing.”

An internationally renowned health innovator, Professor Iain Hutchison is one of the leading authorities on facial surgery research - he even has his own TED Talk on the subject. He founded Saving Faces - the UK's only charity devoted to the reduction of facial injuries and diseases - and now spends much of his time focused on clinical research around an issue previously neglected.

As a cancer surgeon he was sure his methods were the best, but couldn’t convince his colleagues despite the number of lives he was saving: “The only way to show which was the best treatment was through clinical research, and the gold standard is the prospective randomised study.”

We spoke to Professor Hutchison about the challenges of clinical trials in surgery and the results they have seen in a mouth cancer study. Listen to the fascinating interview below.

Thursday, September 1, 2016

Integrating the Digital and Physical Supply Chain: Optimal Performance, Reduced Risks, and Lower Costs

By Jonathan Cousins and Claire Voigt, Almac

The pharmaceutical industry is accustomed to thinking of the clinical trial supply chain as having two distinct parts: the digital supply chain, meaning the technology required to manage and monitor drug inventory, and the physical supply chain, or the processes involved in preparing and shipping drug products from depots to sites. However, that delineation was created simply because most vendors supporting the industry provide only half of the equation.

The delineation between the digital and physical supply chain need not exist; in fact, ideally, it should not exist. The digital and physical aspects of the supply are inexorably linked across all phases of the trial, starting with forecast and moving onto the bulk input and preparation of finished goods ready to ship from the depot… to monitoring sites’ inventory and patient dispensing… to managing returns and accounting for the disposition of all products. The extent to which the supply chain technology and supporting services are integrated directly affects the amount of oversight, degree of alignment, number of custom system integrations, and level of risk involved in ensuring successful trial operations. The more coordinated the effort, the better the ability to meet the trial demands in a cost effective, streamlined way.

Wednesday, August 31, 2016

History with a Window Seat: How the Cancer Moonshot Impacts Clinical Trial Opportunities for Rare Disease Patients

Clinical trials represent one of the most effective ways to find new treatments for cancer patients. However, trials for rare cancers can face significant difficulties, such as attracting an adequate level of funding or finding enough patients who meet the criteria to participate.

An example of this conundrum is mesothelioma research and treatment. Mesothelioma is a very rare form of cancer that can form in the linings of the lungs, abdomen, or the cavity around the heart. Only about 2,000 - 3,000 people are diagnosed each year. Most of the time it is caught at a late stage and life expectancy for patients is usually measured in months not years.

Given all of these factors, finding enough individuals to participate in a mesothelioma clinical trial can be extraordinarily difficult. Patients who are eligible can be too ill and cannot travel to where the trial is being held. Given the poor prognosis of mesothelioma, many patients who have the disease are willing to try experimental treatments of all kinds, even if they offer little hope of overcoming the disease.

With most patients being advanced in age (the average is 74 years old), most have trouble navigating online clinical trial information. Databases like and NASA are tough nuts to crack for many users, and finding a trial that can actually help them in this deluge of information has proven to be very difficult.

Tuesday, August 30, 2016

WEBINAR: How can you best manage performance in an extended clinical research team?

Join John Faulkes on Wednesday 14th September, 2pm BST

A clinical project manager is likely to be leading a team of experts, many or all of which do not report in directly. Some of these will be from various functions inside the sponsor company, others will be from the CRO. The team members may be contributing to many different projects at various times, they all have their own line managers, and their attention is divided and sometimes competed for.

Consultant and trainer John Faulkes is leading a free webinar on Wednesday 14th September at 2pm BST exploring techniques for managing performance in an extended clinical research team without direct authority. The webinar will focus on a number of special tactics that project managers can employ on a week by week basis that will help them deal with this, and outsourcing managers can employ when looking at more infrequent project / relationship team builds or reviews. Key questions include:

  • - What is the cross-functional leader’s real source of authority? It’s often not exploited.
  • - How should work packages be delegated so as to increase the likelihood of delivery? When things are not delivered, what does the leader and the team often not hear, that they need to?
  • - Why does the ‘penalty clause’ provide such poor motivation to get things right?
  • - How can a critical piece of feedback, and a request for improved performance, be delivered to people who do not report to you?
  • - How can you ‘change the game’ gradually and take time to build your confidence?

When?  Wednesday 14th September at 2 -3pm BST
Who? John Faulkes is a consultant, trainer and coach, helping companies and teams to work together more effectively in projects, alliances and partnerships. He is a committee member of the Pharmaceutical Industry Project Management Group and a founder of The Collaboration Project, a network for project, alliance and outsourcing professionals.

Monday, August 29, 2016

Preventing Inconsistencies in Study Conduct and Protocol Noncompliance Across Sites

by Shree Kalluri

Clinical trials are more complex than ever and it’s important to make sure a study is being conducted in the same manner across sites. However, ensuring consistency across multiple sites for any aspect of a clinical trial can be more difficult than one would expect. Some inconsistencies at the site-level are unknown to many sponsors, resulting in both efficiency and quality problems in the industry.

One example of this industry challenge stems from having each research site transform the schedule of events, also known as the time and event schedule, into their local clinical trial management system (CTMS). This transcription requires sites to review and interpret the protocol document and build it out as a protocol calendar in their CTMS. The protocol calendar, a schedule of treatments and tests to be completed by a participant on a study, is one of the most important aspects of a clinical trial, and any deviations from the calendar can have detrimental consequences. The calendar is connected and tied to other downstream activities and uses within the site’s CTMS, making it more powerful than a static spreadsheet or PDF.

This process can be replicated from ten to a hundred times based on the size of the trial and the number of participating sites. With so much duplicated effort, this method is unnecessarily complicated, administratively expensive, and fraught with the potential for costly errors.