"Secrets to Successful Global Clinical Trial Sites in Emerging Regions: Hint: There is None !"
FDASmart 60-Minute Webinar on Pharmaceutical Emerging Series:


Date: November 18th-2010
Time: 2pm  - 3pm EST


Bill Cooney - CEO - Medpoint Communications  
Dan McDonald -
VP - Business Development, Excel Life Sciences

Conducting Clinical trials has never been an easy task.

With the globalization of drug development, the clinical trials industry has reached an exciting yet critical crossroads in which success or failure can depend on your knowledge of the various markets and how to survive in them.

Globalization of clinical trials  in emerging pharmaceutical regions adds yet another layer of complexity.

Outsourcing clinical trials to emerging regions is now a mandate to gain strategic and competitive advantages to drug development. So how do you reconcile a site-centric approach to clinical study management without compromising global GCP standards specially when remote emerging regions are part of the clinical study”?

 Doing clinical trial studies in emerging regions has steep  challenges and pitfalls if not done right despite the promise of great benefits.

Growing in importance is the need to develop strong relationships, especially with hospitals, service providers and other stakeholders. It is also critical to make general and public contributions to the growth of a healthy and successful clinical research enterprise in that region.

Is there a SECRET to getting things right?  Clinical trial sites are WHERE THE ACTION HAPPENS so it is no surprise that  OPTIMIZING  investigational site meetings  with ALL STAKEHOLDERS is one of  the KEYS to CONDUCTING SUCCESSFUL GLOBAL CLINICAL TRIALS. 

This is easier said than done.

The effective training of study site personnel has grown in importance during the past few years with clinical trial designs and trial-related procedures becoming increasingly complex.

As research activities have expanded into emerging regions of the world, the issue of site training and preparation has gained an even greater sense of urgency. Today, global study teams also generally understand the value of supporting study sites in emerging regions with effective training.

But the issue lingers: what are the necessary steps for delivering high-quality training on a global basis?

Knowing that language, culture and local regions differences matter is one thing. Factoring them into your best practices with GLOBAL investigational trial  sites is another.

What are your goals when you hold investigational meeting?

Do they include:

  1. Achieving  consistent and accurate performance of study tasks?
  2. Information sharing and education?
  3. Discussion and agreement?

Do you know why emerging regions have special needs for training and communications?

Can you describe the differences in learning styles that occur in emerging regions?

How does one factor  into clinical trial recruitment that in India, for example, clinical trial patient recruitment involves a spouse or other members of the family? Or that in Latin America, one needs to create and nurture a social relationship first before conducting business with investigators ?

The secret to conducting successful clinical trials sites in emerging region is that  THERE IS NONE.

The recipe for success in conducting successful clinical trials in emerging regions demands that YOU  DO MORE ! 

 ►Understand WHY AND HOW clinical trials are perceived differently
 ►Develop custom training plans for investigational sites to factor in cultural differences and local regulatory best practices (or lack there of !)
► Train more  since ‘one size does not fit all’ !

 Actively  working with sites & conducting global   clinical study oversight using today’s distance and learning technologies  is achievable despite the emerging regions investigational site challenges assuming we have the necessary planning  &  tools work with.

Whether your interest lies with:

◉ Getting CONTROL BACK of your global study sites !
◉ Learning  strategies and technology/tools to maintain frequent and consistent communication with global sites on different time zones
◉Creating an on-demand platform to deliver on-going TRAINING and MAINTAINING SITE PERFORMANCE METRICS
◉ Understanding/Managing local investigator sites in order to optimize  Asia’s large population pool of treatment naïve patients  in emerging regions

Can you afford not to LISTEN to EXPERTS WHO HAVE “BEEN  THERE  and DONE THAT in emerging regions?

Speakers Background:

Dan McDonald: - VP-Business Development, Excel Life Sciences

Dan McDonald is VP, Business Strategy at Excel Life Sciences. With over 12 years of industry experience working with biopharmaceutical companies to assist them with their global clinical research strategies, patient recruitment and site selection, Dan understands the different challenges the industry is facing and the dynamics that are rapidly expanding its reach across the globe including India.
Bill Cooney: - CEO, Medpoint Communications

Bill Cooney started his career at Abbott in 1983, where he managed neuroscience products, notably the Depakote brand. In 1990 Bill founded MedPoint as an independent medical education group.  As President and CEO, Bill has presided over MedPoint’s transformation into a leading provider of diversified digital solutions for e-meetings, e-portals, learning centers and study document exchange systems, addressing special challenges in clinical research for CROs and global biotech/ pharma companies including those conducting clinical trials  in emerging regions like China, India and Latin America.

During the webinar-our moderator will interview speakers to probe for answers on questions like:
  1. We keep hearing –patient recruitment works faster in India or China -but is that early lead really maintained considering the burdens of regulatory compliance issues posed by Indian health authorities and agencies?

  2. Language adds to the complexity of managing sites especially in China.
    Translations add to the costs of site docs, maintaining oversight, etc.
    How much of a factor does language play in the selection of sponsors for their clinical trial site selection?

  3. What emerging region in your opinion presents the most challenging learning style to cope with?

  4. Learning  & retention is often enhanced when done in an  INTERACTIVE fashion.
     How do the media or Web tools & technologies enhance on-demand learning  so it COMPLIMENTS and not COMPLICATE site training considering there is significant time zone differences? Email works great to cope with that—can we say the same for site management web technologies?

  5. It’s often said that India India is a land of contrast. Can you comment on that note with regards to India as as an emerging clinical trial site destination ?

  6. US FDA has established new presence and offices in China, India, Latin America and Middle East.
What now? How does that affect bioresearch monitoring in emerging regions?
Past Webinar Recording CD are available for purchase
For more information contact Ram Balani at 516-515-9642 or email at rbalani@fdasmart.com