Clinical Trial Audit and Monitoring Services

Robust trial execution demands meticulous monitoring services adhering to Regulatory standards, At Freyr, our focus on trial-related studies and a proactive approach to quality control with our skilled clinical team delivers personalized solutions tailored to diverse therapeutic areas and compliant with Regulatory guidelines.

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Clinical Trial Audit and Monitoring Services - Overview

Clinical trial audits and clinical trial monitoring guarantee that the trial data is accurate, complete, verifiable, and in agreement with ethical and scientific norms. Clinical trial monitoring quality is the basis for efficient execution, and the success of each clinical trial depends on it. Robust clinical trial monitoring is vital to protect the integrity of the scientific data and yield valid Regulatory data. To ensure that clinical data adhere to the protocols and international guidelines, organizations must opt for clinical trial audits and monitoring services that can well-manage intricacies of bioavailability and bioequivalence studies.

Freyr’s clinical trial audit and monitoring services consist of a skilled team that showcases innovative problem-solving talents while monitoring everything from straightforward, 2-way, cross-over Bioequivalence (BE) and Bioavailability (BA) studies services to large, complex, steady-state BE and BA study services. Freyr also provides independent clinical trial monitoring and auditing services for clinical and bio-analytical phases of the BE and BA studies through its highly qualified and experienced clinical monitoring team.

Our clinical trial audit and monitoring services assist in quality control to maintain the integrity of the clinical trial per standards set by ICH Good Clinical Practice (GCP), the United States Food and Drug Administration (US FDA), Europe, Middle East, and Africa (EMEA), the National Health Surveillance Agency or ANVISA (Agência Nacional de Vigilância Sanitária) regulations, etc.

To provide continued clinical trial monitoring, our clinical experts guide in preparing and reviewing clinical Standard Operation Procedures (SOPs). Freyr’s proactive research-site approach helps you access the best sites following a thorough audit of feasibility and analysis of the CRO/study site, along with high-quality monitoring throughout the trial duration, to ensure compliance with the applicable regulations and guidelines.

Clinical Trial Audit and Monitoring Services

  • Clinical trial monitoring services for phase I trial and bioequivalence studies.
  • Bio-analytical monitoring of phase I trial and bioequivalence studies.
  • Auditing of BE CRO/study site.
  • System audits of phase I-BE CRO/study site.
  • BA/ BE study services.
  • Preparation and review of clinical SOP.
  • In-depth clinical trial audit and monitoring knowledge perfectly integrated with IT capabilities.
  • Complete understanding of the complex drug development process, including NCEs, generics, biologics, and biosimilars that facilitate clinical monitoring.
  • Vast experience in dealing with clinical trial audit imperatives across multiple therapeutic areas like oncology, cardiovascular, psychiatry, respiratory, renal, gastrointestinal, etc.
  • Defined in-house processes for clinical trial monitoring to provide thorough scientific, medical, editorial, and quality control reviews before the sponsor review.

Partnering with Leading Organizations

 

Medicinal Products

Medical Writing

India

A big thanks to the Freyr team for the support they have provided to us on priority. We really appreciate the extra effort that the Freyr team has put into providing the reports on time. We are looking forward to a continuous business association with Freyr.​

Head of Quality Assurance​

India-based, Leading Pharma Contract Manufacturing Organization​

 

Medicinal Products

Medical Writing

India

A big thanks to Freyr team for the support they have provided to us on priority. We really appreciate the extra effort that the Freyr team has put into providing the reports on time. We are looking forward for a continuous business association with Freyr.

Head of Quality Assurance

 

Medicinal Products

Medical Writing

UK

We are extremely happy to inform you that the BLA was successfully submitted to the FDA. We convey our sincere gratitude to the Freyr team, who worked diligently, tirelessly, and very closely with our Bridgewater and Beijing teams over the past several months to accomplish this monumental feat on time. Freyr’s team went beyond the call of duty to make this BLA submission come true. We truly appreciate Freyr’s flexibility and eagerness to work with us to accomplish aggressive goals. Look forward to your perennial support and our continued relationship and beyond. ​

Global CMC Technical Lead​

China-based, Leading Innovator Pharmaceutical Company​

 

Medicinal Products

Medical Writing

USA

Thank you, Freyr team. I appreciate your professionalism, dedication, and hard work. You’ve gone above and beyond to ensure all deliverables were met ahead of schedule throughout the project and have done a great job managing a challenging group of products. I appreciate your attention to detail and follow-up on the large workload you’ve managed. It’s been a pleasure working with you, and I wish you and your family all the best in the future!​

Director, Global Labeling Management – Labeling Cluster Head Global Product ​ Development, Global Regulatory Affairs

US-based, Multinational Pharmaceutical and Biotechnology Company​

 

Medicinal Products

Medical Writing

Vietnam​

Thank you so much for being a great partner in our Regulatory compliance journey.

As Asian countries move towards having safety assessments as a key requirement, your support has helped us significantly in fulfilling those requirements well ahead of our competitors in Vietnam. ​

In fact, I shared your contact with our regulatory officers so that they can share it across the industry if the safety assessments become necessary.

Lead, R&D/Personal Care

India-based, Multinational Consumer Goods Company​

 

Medicinal Products

Medical Writing

USA

Kudos to you all for the brilliant teamwork !! Alone, we can do so little; together, we can do so much.

Look forward to the next milestone and collaboration on new projects in the future.

SVP - R&D ( Finished Dosage Form)​

US-based, CRO Company that Focuses on Material Science and Engineering for Drug Development​