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 TEMPO™, 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. Below are just a few of our experts.

Barbara Geiger, BSN, RN

Barbara has been in the clinical research and development industry for more than 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.”

Mark Shapiro

A pharmacologist by training, Mark has almost 20 years of experience spanning virtually all aspects of drug development. He completed an MBA at Duke University’s Fuqua School of Business.
Prior to Duke, Mark did master’s 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.”

Marie Hanley

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

With a Bachelor of Science 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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