- PROMETRIKA Achieves Accreditation in Targeted SDV
- PM Considerations for NDA / MAA Submissions
- SAD or MAD But Not Alone: Medical Writing for Small Biotechs
- Our COVID-19 Response: Meeting Your Needs in These Unprecedented Time
- How Risk Based Monitoring Fits into an Overall Clinical Development Quality Management Approach
- PROMETRIKA Partners with Comprehend to Enhance its Full Service Clinical Trial Offering
- PROMETRIKA's President and CEO, Miganush Stepanians, PhD moderated MassBio's December Forum
- PROMETRIKA and Karyopharm: Partners in Global COVID-19 Trial
- Giving Back to the Community
- April 20 2020
Analyzing 'Missing at Random' Data
MassBio 2020 Annual MeetingAugust 26-27 2020Cambridge, MA
- September 23-25 2020 Rockville, MD
ASA Biopharmaceutical Section Regulatory-Industry Statistics Workshop 2020
- September 30-1 2020 Boston, MA
Outsourcing in Clinical Trials New England 2020
M. Alexandra Rohall
“PROMETRIKA’s experienced Regulatory Medical Writing professionals develop clear, concise, and impactful summaries of clinical data for our sponsors. Across a broad portfolio of therapeutic areas, we have provided the documents that support first-in-human studies through marketing authorization submissions. We’re proud to have been chosen by our sponsors to support more than 17 US and European submissions for drug and device approvals. In addition to regulatory documentation, our writers work with sponsors to create posters, manuscripts, and post-marketing informational materials.”
M. Alexandra Rohall
FOCUS ON RARE DISEASES
We have experience in rare disease clinical trials that includes more than 60 studies in a broad range of indications.
FOCUS ON ONCOLOGY
Oncology represents one of PROMETRIKA’s top three therapeutic areas of experience.
PROMETRIKA was founded in 2003 and started operations as a data management, biostatistics, and medical writing functional service provider. In 2007, we added clinical operations and pharmacovigilance and became a full-service Clinical Research Organization. Since then, PROMETRIKA has provided more than a decade of experienced, professional support to local, national, and international clients and has gained a reputation for quality and excellence. Let us tell you about our journey!