Clinical Trial Monitoring

 

Clinical Trial Monitoring - Overview

Clinical trial monitoring ensures that the trial data is accurate, complete, verifiable, and in agreement with ethical and scientific norms. Robust clinical trial monitoring services are vital to protect the integrity of scientific data and yield valid Regulatory data. To ensure that the data adheres to protocols and international guidelines, organizations must opt for an expert medical writing partner well-versed in audit and monitoring.

Freyr has a highly skilled and innovative clinical trial audit and risk-based monitoring team, which assists sponsors in the clinical and bio-analytical phases of the Bioequivalence (BE) and Bioavailability (BA) studies. Our clinical trial monitoring services excel in quality control by maintaining the integrity of the trial as per the specific standards across the globe. By providing continual clinical trial monitoring, our experts also help in the preparation and review of clinical Standard Operation Procedures (SOPs).

Clinical Trial Monitoring - Expertise

  • Clinical monitoring of phase I trials and bioequivalence studies.
  • Clinical trial monitoring of phase I trials and bioequivalence studies.
  • Bio-analytical monitoring of phase I trials and bioequivalence studies.
  • Auditing of BE CRO/study site.
  • System audits of phase I-BE CRO/study site.
  • BE study services.
  • BA study services.
  • Preparation and review of the clinical SOPs.
Clinical Trial Monitoring

Celebrating Customers Success

 

Medicinal Products

Regulatory Affairs

India

Thank you for the timely support over the weekend, which allowed us to resubmit quickly after being notified. This continuously demonstrates Freyr's commitment towards our company’s milestones.

Director - Global Regulatory Affairs – Operations

India-based, Global Top Generic Pharma Company

 

Medicinal Products

Publishing

UK

I am sure you have heard by now that we have received our first-ever approval from the FDA for our Brands division. This is a major milestone for us as well as for my team here in Reg Ops. I would be remiss if I didn’t point out that we would not have been able to do this without the help of your dedicated team. From the original filing, then the following year of responses, all helped get us to final approval.

Thank you Freyr team for a job well done!

Sr. Director, Head of Regulatory Operations

Ireland-based, Global Specialty Pharmaceutical Company

 

Medicinal Products

Regulatory Affairs

USA

Please relate to the team the excellent job they have done on the IND reactivation. Specifically, the high-quality module 3, written by Freyr. It was very comprehensive, very few revisions were required, and we had no questions from Health Canada or FDA. No CMC questions: that was a first for me. So very responsive to my many requests, which I am sure can be frustrating but always helpful while producing excellent work.

Thank you for always being available and responding quickly and comprehensively to all my requests.

What a great team you have, Freyr.

Lynne McGrath

Regulatory Consultant

 

Medicinal Products

Regulatory Affairs

USA

Congratulations!!! ​

Thanks for your great support for a successful ANDA filing, especially to the publishing team. Heartfully appreciate their last hours of hard work.

Assistant Manager​

US-based, Leading, Complex Generic Pharmaceutical Products Company​

 

Medicinal Products

Regulatory Affairs

USA

Thank you all for the great support!​

CEO

US-based, Leading Innovative Pharmaceuticals Company​

 

Medicinal Products

Regulatory Affairs

USA

The ANDA receipt has been received! Thank you very much for your hard work, patience, and support for our work over the last couple of months. We are delighted that we were able to meet the timeline and hit an important corporate goal of our young company. ​

Thank you again, and we look forward to working with your team on the next project!

Senior Director of Business and Product Development​

US-based, Leading Innovator Pharmaceuticals Company​