Tag Archives: Clinical Trials

Sandra “SAM” Sather, VP, Clinical Pathways, Regulatory & Quality, TrialConsent – CRF Health

SAM White Background smile-014 - Web Sam’s current focus of consulting is to promote clinical quality systems for sponsors/CROs, investigators, and clinical research institutions. She has over 30 years of clinical experience, a Bachelor of Science degree in Nursing and a Master of Science degree in Education with a Specialization in Training and Performance Improvement. 

Sam has served many roles in clinical research, including site study coordinator and manager, sponsor and CRO monitor, quality assurance auditor, risk manager, trainer, and performance management consultant. She has held clinical research industry certifications for over 15 years by the Association for Clinical Research Professionals (ACRP). Sam is a current member of the ACRP Academy Board of Trustees and Regulatory Affairs Committee (RAC). She is a frequent subject matter expert for GCP regulation and speaker at industry conferences. Sam has authored dozens of competency-based curriculums for various clinical research stakeholders.

What do you hope the audience will learn from this webinar? We hope the audience will learn about the many ways that implementing an eConsent system can significantly support effective sponsor, investigator, and ethics committee oversight and eliminate many common informed consent deficiencies, e.g., wrong version used.

What discussions do you look forward to having with the audience? What do they perceive to be the barrier to eConsent? Commonly it is perceived cost, but this is not always the case. Comparing the manpower for development, oversight, and issues management that can be decreased with the solution, especially overtime, can actually save money.

What do you enjoy most about your role? As a clinical research consultant, I enjoy helping make the way we conduct research more effective and efficient.  I enjoy teaching about quality systems that ultimately better support human subject protection and data integrity.

How did you get into the industry? I was working as an RN in an intensive care unit where there were some clinical trials ongoing and I was the study coordinator.

Where is your favourite place in the world and why?  At home with my family in North Carolina.

Join Sandra “SAM” Sather, CRF Health & Chesapeake IRB in their webinar “Visibility and Oversight: What Paper Informed Consent Isn’t Offering You” on 23rd February at 3PM London/10AM New York.

Register Now!

CRO’s Capitalize on Market Growth with Technology

By Mike Lemons, ArisGlobal

Technology in the handsIn an increasingly challenging and complex regulatory environment, life science and biotech companies are leveraging Contract Research Organizations (CRO’s) to ensure the timely and accurate management of clinical trials for their respective products. Why?

The CRO market is poised for continued growth as new opportunities arise since the increasing costs and complexities of clinical trial management for life science companies make outsourcing more and more appealing. Additionally, many are realizing that managing clinical trials is not a core competency for many companies, the trials are becoming more global than ever before and they just don’t have the expertise to manage global clinical trials effectively.

While some larger companies manage their own trials, others simply don’t have the workforce to support trials. At the same time, technology solutions have grown in availability and simplicity which has further contributed to CRO growth. CRO’s now have access to technology that can grant them easier access and more transparency to data relating to clinical trials.

If you’re interested in learning more about the role CRO’s are playing in today’s clinical trial environment – and how they can boost profits and productivity – register for the webinar today!!

Trials fail due to poor design. Don’t let yours be the next!

Flawed methods in clinical trials have had a big part to play in the poor track record for Neuroscience drug development with consequences for both patients and the pharmaceutical industry.  Nowhere are the consequences for patients more acutely felt than in the area of Alzheimer’s drug development where the industry counts just three Alzheimer’s drug wins in 13 years and 101 losses, according to Pharmaceutical Research and Manufacturers of America (PhRMA). Failed trials also have big consequences for companies, often losing organizations billions in capitalization. In many cases the losses could be avoided through better trial design[1].

Research has shown that clinical programs have a high failure rate, even when drugs are known to be effective. For example, Khan et al. (2002)[2] reviewed the data from nine antidepressants approved by the United States Food and Drug Administration between 1985 and 2000. Of the 92 treatment arms reviewed, less than half showed statistically significant separation from placebo.

Surely we can be doing more at the trial design stage to avoid failed trials. Newer methodologies, such as adaptive designs, patient enrichment and risk based monitoring have been discussed extensively but adoption by the industry has been slow.

In the upcoming webinar sponsored by Covance Inc., leading industry experts share their insights and experiences gathered in the design and execution of novel trial designs in psychiatry – designs focused on speeding availability of effective treatment to patients, selecting patient subgroups most likely to respond and minimizing placebo response rates.

Scott Berry, PhD, President and Senior Statistical Scientist at Berry Consultants, shares his thoughts on how adaptive designs can reduce length and increase flexibility in exploratory trials. Prospective subgroup analysis and wider dose ranges can be studied without increasing sample size allowing for more efficient use of trial budgets.

Sanjeev Pathak, MD, Senior Medical Director at Alkermes Inc., will review how his group has adopted methodologies that reduce the impact of placebo response while lowering sample size by 20-40%. He outlines his group’s reasons for adopting novel trial designs and lessons learned from discussions with regulators.

By attending the webinar you will –

  • Explore how novel trial designs can benefit your Neuroscience development program
  • Examine the pros and cons of implementing adaptive and enrichment designs
  • Identify barriers to adoption and how to overcome them, including organizational, regulatory and resource related barriers

If you’d like to hear more about how trial design can help improve your chances of success, then join me on November 17th for the Covance-sponsored webinar “Innovation in psychiatry trial design – How to improve the probability of success”.

Webinar Details and Registration
Monday, November 17, 2014
10 am New York, US/15:00 London, UK
60 minutes including Q&A

[1]Becker RE, Greig NH. Why So Few Drugs for Alzheimer’s Disease? Are Methods Failing Drugs? Curr Alzheimer Res. 2010 November 1; 7(7): 642–651

[2]Khan A, Leventhal RM, Khan SR, Brown WA. Severity of Depression and Response to Antidepressants and Placebo: An Analysis of the Food and Drug Administration Database. Journal of Clinical Psychopharmacology. February 2002 – Volume 22 – Issue 1 – pp 40-45

Andrew Mitchell, Director Life Sciences Strategy and Product Marketing, Intralinks

Andrew MitchellAndrew has many years of experience working in and with the Life Sciences industry, delivering innovative software solutions through his time with Covance, Relsys, Medidata and BioPharm Systems (Oracle Gold implementation partner). With a focus on Software as a Service, he has a strong belief in providing solutions that simplify and improve the user experience and the relevant subject matter expertise to ensure delivery of real benefits and enhanced compliance.

Andrew will present Intralinks’ webinar “Remote monitoring of Investigator Site Files (Regulatory Binders) and Source Documents” on the 18th September at 11am New York/4pm London. You can register now to reserve your place.

1. What inspired you to get into the industry?

My grandfather was the chief medical doctor in South Africa, my mother is a physiotherapist and my sister a surgeon, so to some extent it’s definitely in my blood. I’ve always been fascinated by technology and the business side to things, so it’s not a big surprise that I’m in this industry.

I previously worked extensively in Pharmacovigiliance (Drug Safety), assisting pharmaceutical companies move from paper to electronic reporting to the regulatory authorities and then for an EDC vendor to run clinical trials that simply would not have been possible using paper CRFs, so joining Intralinks to assist with moving study documents online (both at the sponsor and at the site) was a natural progression for my career.

2. What do you enjoy most about presenting to a live audience?

We’re all in this industry trying to make big changes in the world. Bringing new drugs to market faster and safer truly impacts peoples’ lives.

A live audience, whether at a conference or a small meeting, means I can truly engage with my peers, listen and learn from them.

3. Tell us about yourself; do you have any hobbies or ways to help you relax?              

I enjoy getting lost in a book and cooking, mountain biking and scuba diving with my wife. We also have two affectionate Persian/Bengal cats and playful chocolate Labrador – who keep us entertained for hours.

4. What’s your favourite flavour of ice-cream?


5. Where is the one place in the world that you would like to visit and why?

Athuruga Island, Maldives – we had an amazing honeymoon there and would love to return as it’s a magical place – snorkelling with turtles, whale sharks and sheer island bliss.

Remember to register for Andrew’s upcoming webinar where you can ask him questions live on the webinar.