Instat Services
Veristat is a full-service clinical research organization (CRO) dedicated to accelerating clinical development and patient access to innovative treatments. It offers integrated solutions across the entire lifecycle of drug development, including strategic advice, clinical trial delivery, regulatory registration, and post-market solutions. With significant expertise in supporting complex therapies across various therapeutic areas, Veristat emphasizes quality, speed, and effectiveness. The company's services encompass biometrics, medical and regulatory writing, clinical trial resourcing, pharmacovigilance, data monitoring committees, and regulatory affairs. As part of its expansion, Veristat now provides full-service solutions that include decentralized trials, real-world evidence, indication selection using adaptive design, and support for rare diseases and breakthrough therapies. The company is committed to supporting drug developers through every stage of development, ensuring patient safety, regulatory compliance, and successful market entry.
Industries
Nr. of Employees
small (1-50)
Instat Services
Chatham, New Jersey, United States, North America
Services
Operational delivery across all trial phases including monitoring, site management, and trial logistics.
Strategic guidance to achieve clinical, regulatory, and commercialization milestones across development programs.
Preparation and management of regulatory submissions, agency interactions, and electronic dossier formatting compliant with eCTD 4.0.
Clinical data management, statistical analysis, and regulatory reporting of trial data.
Development of clinical study documents, regulatory communications, and marketing application content.
Safety case management, adverse event reporting, signal detection, and ongoing pharmacovigilance operations.
Operational delivery across all trial phases including monitoring, site management, and trial logistics.
Strategic guidance to achieve clinical, regulatory, and commercialization milestones across development programs.
Preparation and management of regulatory submissions, agency interactions, and electronic dossier formatting compliant with eCTD 4.0.
Clinical data management, statistical analysis, and regulatory reporting of trial data.
Development of clinical study documents, regulatory communications, and marketing application content.
Safety case management, adverse event reporting, signal detection, and ongoing pharmacovigilance operations.
Expertise Areas
- Clinical trial management
- Biometrics and biostatistics
- Regulatory affairs and submissions
- Medical and regulatory writing
Key Technologies
- eCTD 4.0 electronic submission standards
- Biostatistics and statistical programming
- Clinical data management systems (CDMS)
- Decentralized trial platforms and remote data capture
News & Updates
Monthly FDA Guidance and Regulatory News Review May 2025
A review of recent FDA guidance and regulatory updates relevant to clinical development.
Webinar: Roadmap to Market Cell and Gene Therapies
An educational webinar discussing strategies for bringing cell and gene therapies to market.
Meeting the Challenges of the Moment in Clinical Development
A discussion on how Veristat supports clients in navigating current challenges in clinical development.
Demystifying eCTD 4.0: What You Need to Know
An overview of the eCTD 4.0 standard for electronic submissions to regulatory agencies.
How to Ensure Successful FDA Meetings - Video Replay
A guide on preparing for and conducting successful meetings with the FDA.
Case studies and strategies for obtaining regulatory approval for rare hematologic diseases.
Monthly FDA Guidance and Regulatory News Review May 2025
A review of recent FDA guidance and regulatory updates relevant to clinical development.
Webinar: Roadmap to Market Cell and Gene Therapies
An educational webinar discussing strategies for bringing cell and gene therapies to market.
Meeting the Challenges of the Moment in Clinical Development
A discussion on how Veristat supports clients in navigating current challenges in clinical development.
Demystifying eCTD 4.0: What You Need to Know
An overview of the eCTD 4.0 standard for electronic submissions to regulatory agencies.
How to Ensure Successful FDA Meetings - Video Replay
A guide on preparing for and conducting successful meetings with the FDA.
Case studies and strategies for obtaining regulatory approval for rare hematologic diseases.