Place header for sub dropdown here

Place sub header for sub dropdown here

Subscribe to Our Blog

A look ahead: Inspection Readiness and SCOPE Summit 2015

By  Fran Ross Fran Ross  on 2015-02-19 10:10:00  |  Featured in  Life Sciences
Fran Ross
Posted By Fran Ross
in Life Sciences
on 2015-02-19 10:10:00

achieving-continual-tmf-inspection-readiness-webinarWe had great attendance at our January 28, 2015 webinar, Achieving Continual TMF Inspection Readiness: a metaTMF Approach to Preparedness and Compliance.  The amount of live participation confirms the continued inspection focus in our industry. 

If you missed it, you can watch the recording or download presentation.

Our bottom line - with the right lens, TMF inspection preparation scrambles - risky, expensive, and time consuming - can become a thing of the past.

That lens is metaTMF, a term we use to deepen the conversation beyond the confines of clinical technologies.  We are fans and proponents of eTMF systems, and we know they cannot deliver inspection readiness out of the box.  metaTMF broadens the scope beyond eClinical to make sure the right people use effective procedures, with robust architecture and smart governance.  metaTMF encompasses well-defined content and data models, configured in well-designed tools, with clear-eyed focus on the necessary system capabilities (rather than over complicate with what’s possible).  And metaTMF governance is driven by actionable metrics to assess the three interrelated areas of health:  individual TMFs, the eTMF system, and the full metaTMF Program.

More meta to follow.  This spring we’ll be delivering both a metaTMF whitepaper, and another webinar on avoiding eTMF implementation snafus.

In the meanwhile, we’ll be at 2015 SCOPE Summit in Orlando February 24-26, which is packed with compelling, next wave trial topics.  And sunshine, very enticing for those subjected to the historic snowfalls back East.

Two SCOPE session questions are topics in high rotation within our team and on our projects:

What makes participating in clinical research difficult for investigators and what can pharma and CROs do to overcome this?

To overcome, move away from sponsor-centric thinking to examine the priorities, drivers and capabilities of the broader ecosystem in clinical trials.  Assess and take action on meeting the needs of key participant groups.  During protocol creation, assess with a potential subject pool if a protocol schedule is manageable, and get their ideas to increase recruitment and retention.  Prior to implementing a site portal, ensure the CRO, Principle Investigator and Site Coordinator don’t have SOP conflicts or technology barriers, and that they are clear on and buy into the value.  It wasn’t so long ago that the early remote data capture projects experienced significant drag when site staff balked.   To remove participation difficulties, apply the lessons to the new trial modalities such as eConsent, virtual trials, collection of mHealth trial data. 

Make the time.  Ask the questions.  Leverage the information.  And always close the loop.  When stakeholders take the time to give their insights and opinions, don’t just thank them, also inform them of decisions and next steps.

What is our ideal future state for clinical research, and what barriers must we overcome to get there?

Barriers remain high for the effective use of the data about clinical trials, impeding the ability to effectively leverage eClinical across the stakeholder community, and to make the final break with paper.  The majority of trial sponsors hold critical master data in multiple eClinical systems and in spreadsheets, if it’s managed at all.  We know in our Clinical Architecture work how vital it is for organizations and their partners to hammer out the agreements on both the data definitions and the source system.  What does trial start mean?  Is the official record in your CTMS, your RIMS, your EDC or in mine?  Once accomplished, the value of this work enables you to repurpose reliable data effectively.  When it’s not accomplished, the costs and effects of workarounds are often hidden.  That is, until something breaks – delays in site activation, data mistakes pushed to ClinTrials.gov, errors in submissions, inspection findings, etc.

If you have struggled with the negative consequences of key stakeholder non-engagement or trial data mismanagement, get in touch.  We focus on turning insights into actions, and actions into continuous improvements, and know these principles apply across the strategic programs landscape as varied as eTMF, RBM, EDC, Portal, IRT, Clinical Architecture, Site Activation, eISF, etc.  At the end of the day, we are all about Solutions.  Delivered.

UPCOMING SCOPE PLENARIES

TUESDAY, FEBRUARY 24

THE INVESTIGATOR’S VOICE AND PATIENT-CENTERED TRIALS

8:25 am Organizer’s Welcome 

Micah Lieberman, Executive Director, Conferences, Cambridge Healthtech Institute (CHI)

8:30 Plenary Keynote Chairperson’s Opening Remarks: Balancing Risk and Opportunity in the Evolving Drug Development World

Andrew Lee, M.D., Senior Vice President & Head, Global Clinical Operations, Merck & Co., Inc.

What is the true current “State of the Union” in our industry and in clinical trials today? Have we over-engineered a process into such complexity that it is doomed to failure and inefficiency? Have we leveraged the technologies available to better develop new medicines and manage trials? How do we re-build credibility in our data and our conduct as an industry?

8:40 The Evolution and Implementation of Patient-Centered Trials

Kathy Vandebelt, Senior Director, Clinical Development Innovation, Eli Lilly and Company

Applying patient-centered healthcare delivery principles to the clinical trial space leads to better outcomes, both for the patient and for the trial. We need to apply lessons learned on the commercial side in the clinical trial world — starting with patient recruitment, to improve the design, timeline and outcomes of our trials. One of the realities in the clinical trial space is the majority of patients and investigators who participate in a study do so only once. How can we become more patient and investigator friendly in an ever increasingly competitive environment?

9:05 TRIAL INVESTIGATOR PANEL: Improve Protocol Feasibility, Trial Conduct and Operations by Learning from a Key Partner in Research

The sharp rise in ongoing clinical research studies with over 5000 medicines currently in development globally, is driving demand for greater participation in research by physicians as well as by patients. However, global investigator turnover rates are high, with 35-55% of investigators not returning to conduct another clinical trial after their first experience. These turnover rates contribute to high site selection, qualification and start-up costs. Come to hear what doctors have to say about the realities of conducting clinical trials today, and what they see as the potential solutions to the current challenges they face. The global community of clinical trial investigators is a common and highly valued resource upon which the pharmaceutical industry relies. Supporting investigators, and helping to optimize how they partner with industry, is a key part of the story of how we continue to develop new therapies for the patients who need them. In the session, the panel of doctors will address the following questions:

  • What makes participating in clinical research difficult for investigators and what can pharma and CROs do to overcome this?
  • What are some of the barriers for investigators when working with pharma or CROs and how can relationships be improved?
  • What innovations can doctors and pharma/CROs collaborate on to improve clinical trial conduct?
  • How can both doctors and industry help support the investigators of tomorrow?
  • How can we support the group of ‘1 and done’ investigators who don’t return for a 2nd clinical trial?

Moderator: Claire Sears, Ph.D., Director, Investigator Engagement, DrugDev

Jorge Lujan-Zilbermann, M.D., Associate Professor, Pediatrics; Director, Pediatrics, Division of Clinical Research, University of South Florida

Ramon Bautista, M.D., MBA, Professor, Neurology; Associate Program Director, Neurology Residency, University of Florida Health Science Center

Mohammad Jahanzeb, M.D., Sylvester Comprehensive Cancer Center, University of Miami Miller School of Medicine

Julio Hajdenberg , M.D., Chairman, Department of Medical Oncology and Hematology, UF Health Cancer Center at Orlando Health

Cathy Benene, Director, Clinical Services, Radiant Research

WEDNESDAY, FEBRUARY 25

EMBRACING OPEN INNOVATION AND COLLABORATION

8:25 Organizer’s Welcome

Micah Lieberman, Executive Director, Conferences, Cambridge Healthtech Institute (CHI)

8:30 Plenary Keynote Chairperson’s Opening Remarks: Open Innovation as a Solution to Clinical Research Bottlenecks

Ibraheem “Ibs” Mahmood, President and CEO, DrugDev

Industry experts have long been proselytizing the need for dramatic change in the drug development process to bring down the cost of development and increase the speed of bringing new drugs to the patients who need them. So why is it taking so long to bring about change in an industry that so desperately needs it? What new developments or technology are there to accomplish the goal of faster and cheaper trials?

8:40 Case Study: Alternative and Lean Approaches to Trial Planning and Execution

Dave Gillogly, MBA, Vice President, Head, Global Clinical Operations, Mylan

Pharma development companies are now able to conduct a large number of clinical trials while maintaining a relatively small footprint. In order to provide appropriate oversight many pharma companies have developed several operational methodologies. These operational practices help ensure outsourced trials maintain high levels of safety, quality, and compliance. This session will cover an overview of these operational methods.

9:05 PANEL DISCUSSION: Open Innovation/Cross-Industry Collaboration and the Current State of Affairs In Pharma

This panel will be a provocative discussion featuring panelists from leading biopharmaceutical companies, the Investigator Databank and TransCelerate who have been improving efficiency and advancing innovation in research and development through open collaboration. Key discussion points:

  • Why is it taking so long to bring about change in an industry that so desperately needs it?
  • What new developments or technologies are there to accomplish the goal of faster and cheaper trials?
  • What are the opportunities and potential risks of publishing clinical trial reports and increasing access to data?
  • How do you foresee the increasing use of EHRs effecting innovative change in the industry?
  • What are your thoughts on the best model for cross-industry collaboration? Are there any examples we can learn from where things haven’t worked?

 Moderator: Ibraheem “Ibs” Mahmood, President and CEO, DrugDev

 Panelists: Kathy Vandebelt, Senior Director, Clinical Development Innovation, Eli Lilly and Company

 Dave Gillogly, MBA, Vice President, Head, Global Clinical Operations, Mylan

 Andrew Lee, M.D., Senior Vice President & Head, Global Clinical Operations, Merck & Co., Inc.

 John Oidtman, Vice President, Clinical Trial Support and Compliance & WW Clinical Operations, Pfizer

THURSDAY, FEBRUARY 26

APPLYING INNOVATIVE TECHNOLOGY TO ENABLE CLINICAL RESEARCH

10:40 Organizer’s Welcome

Micah Lieberman, Executive Director, Conferences, Cambridge Healthtech Institute (CHI)

10:45 Clinical Informatics News Best Practices Awards

Allison Proffitt, Editorial Director, Bio-IT World & Clinical Informatics News

11:00 Plenary Keynote Chairperson’s Opening Remarks: Digital Tools Making an Impact on Clinical Research

Craig Lipset, Head, Clinical Innovation, Worldwide Research & Development, Pfizer

Digital tools including mobile, social media, and leveraging diverse data sets are making an impact on clinical research today, from supporting site selection to patient recruitment and retention to more efficient data capture. Looking ahead, the evolution of these tools brings the potential to radically transform clinical development through deep phenotyping of patients and roles for digital tools as diagnostics or co-therapies. What organizations are best positioned to leverage these new opportunities?

11:25 Cross-Pharma Collaboration in Clinical IT

Francis Kendall, GLIDE Future Investigation Team Lead & Global Head, Statistical Programming and Analysis, Genentech

This talk will discuss collaboration between several pharma companies with the prime objective of devising solutions to the challenges that we face as an industry. This cross-pharma consortium focused discussions on technology, standards and data with a view to creating a common framework for how we process data especially in the changing data landscape. Key focus areas included: Transition to CDSIC, Data Aggregation (including broad categories of data - Clinical Trial data, Payer databases, Registry data, Electronic Medical Records Genome data, Biomarker data and Legacy data), key technologies related to data warehousing/data reporting, validation of data analysis tools and open source approaches.

11:50 Using Predictive Analytics to Drive Site Health and Quality

John Oidtman, Vice President, Clinical Trial Support and Compliance & WW Clinical Operations, Pfizer

In Clinical Research we are often finding errors that have occurred in the past. This “find and fix” mentality has shaped many processes that we rely on to oversee an investigative site. Pfizer has implemented a methodology that provides a more proactive and predictive approach to site quality. This presentation will provide an overview of the implementation of a predictive analytics methodology that drives site health.

12:15 Pharmacogenetics as Innovative Clinical Drug Development

Gregory Opiteck, Ph.D., Senior Principal Scientist, Clinical Pharmacogenetics, Merck & Co., Inc.

Our understanding of the consequences of human genetic variation, on the practice of interventional therapeutic medicine, is maturing at a rapid pace. Today, many drug development efforts include evaluation of genetic determinants of drug response. Pharmacogenetic (PGx) data are now being used to impact drug development strategy and the clinical use of drugs. This presentation will highlight methods used to leverage PGx in clinical research and thereby generate data that create new scientific and commercial opportunities.

12:40 PANEL: Mobile Tech, Realworld Data and Innovative Platforms to Enable Trial Operations and Research

An exciting universe of new tools and platforms are becoming available for the clinical trial professional. From leveraging data both old and new, to cutting edge digital tools, what barriers must we overcome to fully appreciating an impact on our development programs?

  • How can organizations position themselves to generate impact and value in using new tools and platforms?
  • What is our ideal future state for clinical research, and what barriers must we overcome to get there?
  • What new tools can conference attendees begin to leverage immediately?

Moderator: Craig Lipset, Head, Clinical Innovation, Worldwide Research & Development, Pfizer

Panelists: Francis Kendall, GLIDE Future Investigation Team Lead & Global Head, Statistical Programming and Analysis, Genentech

Munther Baara, Senior Director, Development Business Technology, Pfizer

Gregory Opiteck, Ph.D., Senior Principal Scientist, Clinical Pharmacogenetics, Merck & Co., Inc.

1:10 Closing Remarks

Register Now - Achieving Continual TMF Inspection Readiness
Fran Ross

Fran Ross

Connect with me on 

Fran joined Paragon Solutions in April 2012, and is currently Associate Director in the Clinical and Regulatory Optimization practice. She previously worked at Genzyme / Sanofi for more than a decade, and has more than 20 years of academic and industry clinical and process expertise. She presents frequently at industry conferences, and is a member of several industry initiatives, including TMF Reference Model, OASIS eTMF Interoperability, and ACRES.

View Comments