Clinical Study Management

We can manage all aspects of your clinical study including Project Management, Regulatory, Biostatistics, Site Selection and Feasibility, as well as eCRF design and configuration.

Medical Monitoring Services

We have a complete team of global CRAs and Lead CRAs providing Quality Control Visits as well as Co-Monitoring Visits and more.

Medical Writing

Our Medical Writers take care of all of your medical writing needs including Protocol Writing, SRM, CMP, Clinical Study Reports, Publications and Manuscripts, IND Preparation and NDA Section Writing.

Safety / Pharmacovigilance

Our Medical Monitoring Team can manage all of your Safety and Pharmacovigilance needs including Safety Management Setup, AE / SAE Case Processing, Safety Narrative Writing and Safety Report Submissions.

 

Auditing Services

Our Auditors can tackle all of your auditing requirements including Auditing of Sponsors, CRO's and Vendors, Compliance Audits and Project Audits.

Call Us Today!

Our team of experts are ready to assist you with your projects today. Call now and speak with our team about your specific requirements.

Jason Rubine

BARDA to Fund NexoBrid Expanded Access Treatment Protocol for Thermal Burns

By Jason Rubine / 30 May 2019 /

AMBRIDGE, Mass., May 29, 2019 (GLOBE NEWSWIRE) — Vericel Corporation (NASDAQ:VCEL), a leader in advanced therapies for the sports medicine and severe burn care markets, today announced that the U.S. Biomedical Advanced Research and Development Authority (BARDA) has agreed to fund the NexoBrid® expanded access treatment (NEXT) protocol. The NEXT protocol is being conducted under…

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Statement by FDA Commissioner Scott Gottlieb, M.D., Director of FDA’s Center for Drug Evaluation and Research Janet Woodcock, M.D. and Director of FDA’s Center for Biologics Evaluation and Research Peter Marks, M.D. on Expanded Access –Looking Forward

By Jason Rubine / 28 May 2019 /

For more than 30 years, the FDA has supported patients’ access to investigational medical products for treatment, outside of participation in a clinical trial, when appropriate. The FDA remains deeply committed to this effort. Helping to facilitate access to promising medicines for patients with serious or immediately life-threatening diseases or conditions when no comparable or…

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FDA Warns Against the Use of Unauthorized Devices for Diabetes Management

By Jason Rubine / 22 May 2019 /

Today, the U.S. Food and Drug Administration is warning patients and health care professionals of risks associated with the use of unapproved or unauthorized devices for diabetes management, including continuous glucose monitoring systems, insulin pumps and automated insulin dosing systems. In the safety communication issued today, the agency noted that the use of unapproved or…

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FDA approves first drug designed to prevent chronic migraines

By Jason Rubine / 20 May 2019 /

The first medicine designed to prevent migraines was approved by the Food and Drug Administration on Thursday, ushering in what many experts believe will be a new era in treatment for people who suffer the most severe form of these headaches. The drug, Aimovig, made by Amgen and Novartis, is a monthly injection with a…

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