Safety & Regulatory Compliance for Clinical Research
Our experienced team of statisticians, clinical project managers, nonclinical developers, and medical writers provide you with expert safety and compliance consultancy, to ensure your patients’ safety and protect your trial integrity.
Keeping Ahead of Drug Safety: From Concept to Market
Drug safety and data monitoring professionals navigate a complex landscape, balancing the need for rapid clinical development with stringent regulatory requirements. The task is compounded by the increasing complexity of clinical trials, which often involve adaptive designs and complex endpoints. Our experts provide you with essential guidance and support, ensuring compliance and safeguarding patient safety through every phase of preclinical and clinical development.
Contact usCompliance with regulatory guidelines
Our medical writers support your regulatory compliance and help you convey scientific research to diverse audiences.
Efficient and informed Independent Data Monitoring Committee (IDMC) recommendations
We know what belongs in an IDMC report, and provide a concise, bookmarked document.
An experienced global panel of experts
Subject matter expertise in your IDMC membership is critical. We have relationships with an extensive global panel of experts, spanning all therapeutic areas.
Mitigate risks and ensure compliance
Our effective clinical project management ensures on-time, within-budget, and high-quality results.
Your Trusted Partner for IDMC Solutions
The increasing complexity of clinical development programs demands independent evaluation of interim clinical data through IDMCs to safeguard patient safety and trial integrity. We have expertise in all major therapeutic areas and experience in handling incomplete data, adaptive designs, and complex endpoints.
Our Axio® experts can:
- author and review IDMC charters
- design and program IDMC reports
- facilitate meetings and data presentations
- address missing and unclean data issues crucial to accurately presenting and representing data to IDMC members.
We also have relationships with an extensive global panel of experts, spanning all therapeutic areas, should you require assistance in building your committee. This service includes member contracting, honoraria handling, and training.
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Ensure Drug Safety and Efficacy While Increasing Regulatory Compliance
Our integrated approach to drug development encompasses clinical pharmacology, clinical project management, medical writing, and nonclinical development, helping you to ensure safety, efficacy, and regulatory compliance from concept to market.
We specialize in optimizing dosages for safe prescribing, facilitating drug-drug interaction assessments and supporting post-marketing activities. Our clinical project management expertise guarantees you timely, cost-effective outcomes while adhering to clinical development regulations. Through effective sponsor oversight, we help you maintain trial integrity and compliance.
Learn More40
Years of experience in IDMC projects.
>1,000
DMC projects, including trials from industry, academia, and government
400
Annual IDMC meetings
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