Clinical Operations Expertise

Our experience is broad, but our expertise runs deep. With more than 80% of our clinical operations experts having seven or more years of relevant industry and trial experience, we pride ourselves in our unmatched expertise in the operational, regulatory, and scientific aspects of your clinical trial.

While our services are amplified by our technology eClinical platform, our people – who share a vision of technology as a tool to bring unsurpassed efficiency and quality – are at its core. As a whole, we are guided by the common philosophy that integrating technology with clinical research optimizes project performance while containing costs.

When you’re looking for a clinical research partner, you need someone who understands and appreciates the unique needs of your program – a true partner that can act as an extension of your team. What’s one of the most important steps in building a successful partnership? Getting to know your team members – their expertise, areas of strength, and individual qualities they bring to your project.

Barbara Geiger, BSN, RN

Barbara has been in the clinical research and development industry for over 25 years. She is an executive clinical operations professional with extensive experience in oncology and CNS drug development.

“Therapeutic experience is not the only thing that matters when selecting a CRO or assigning a project team member. It is really operational knowledge and experience that make the difference.”

Nikolas Burlew

Nik is a Regulatory and Strategic Development QA professional working under GMP and GLP regulations providing auditing, training, system development, and project management services, in addition to authoring CMC sections for US and EU applications.

“The most important consideration a client should take when undertaking a clinical research project is that ALL drugs going into humans MUST follow good manufacturing practices. Engaging an experienced partner helps avoid not complying with GMP rules and regulations.”

Chris Wang

Chris is a pharmacist with a Master Degree in Pharmacology. A successful pharmaceutical executive, with over fifteen years of solid experience in presiding over clinical trials and multinational companies including GlaxoSmithKline, Merck and Bayer.

Chris has always been an invaluable asset to the various companies served particularly in project management for both ethical drugs and vaccine studies. The diversity of her expertise in clinical operations, project management training, and CRO management is the vital essence of the success.

Mark Shapiro

A pharmacologist by training, Mark has almost 20 years of experience spanning virtually all aspects of drug development. Mr. Shapiro completed an MBA at Duke University’s Fuqua School of Business.
Prior to Duke, Mark did Masters and Doctoral work in pharmacology and biomolecular pharmacology at the Boston University School of Medicine. He received a Bachelor’s degree in chemistry at Virginia Tech.

Ofelia Rodriguez Nievas, MD

With almost 30 years of experience as a Medical Oncologist, Ofelia has been on both sides of the clinical research counter: as an investigator while she was still practicing, and then on the clinical operations and medical affairs side after joining the CRO industry over a decade ago. Her main areas of expertise include oncology and conducting clinical trials in Latin America.

“At Clinipace, we go to work every day with the goal of pursuing new therapies through collaboration in order to bring better treatment options to those who need them.”

Brenda Fielding

Brenda has more than 25 years of experience in the pharmaceutical and biotechnology industries, primarily in the area of drug and biologics regulatory affairs.

“My ‘a-ha!’ moment was witnessing the speed at which regulatory landscape is changing. Now it’s more important than ever to have a partner with regulatory expertise to ensure that regulatory strategies and alternatives are considered at every step to help you gain product registration.”

Roger Morgan, M.D.

Dr. Morgan has extensive experience in global medical affairs with both pharmaceutical companies and CROs. While trained as a surgeon/critical care intensivist, he spent much of his industry career focused on cardiovascular research.

Prior to Clinipace, Dr. Morgan served as the Medical Director, then Chief Medical Officer at Kowa Research Institute, where he worked on multiple cardiovascular, endocrine, ophthalmologic, and other therapeutic programs, and evaluated multiple preclinical molecules and potential in-licensing candidates in these areas.

Marie Hanley

Marie has worked in the clinical research industry for over 28 years. Over the past 9 years, she has been in global regulatory and quality assurance roles.

With a B.S. in Nursing and post-graduate work in Biostatistics, she began her research career as a research nurse and study coordinator. Marie is a champion of compliance and process improvement.

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