WEF Clinical, founded by ALS researcher Dr. Wilbert E. Frank, is a full-service Clinical Research Organization offering comprehensive services including project management, site management, clinical monitoring, and data management for pharmaceutical companies, supporting Phase I-IV clinical trials with meticulous execution and compliance.
WEF Clinical provides a comprehensive suite of Regulatory Affairs services to ensure your clinical trials meet all necessary regulations and standards, facilitating smooth progression from initiation to approval.
WEF Clinical provides a comprehensive suite of Regulatory Affairs services to ensure your clinical trials meet all necessary regulations and standards, facilitating smooth progression from initiation to approval.
Regulatory Strategy and Consulting
We develop tailored regulatory strategies to align with your clinical trial goals and provide expert advice on regulatory requirements and best practices.
Regulatory Submissions
Our team prepares, reviews, and compiles all necessary documents for regulatory submissions, including INDs, CTAs, and NDAs. We utilize state-of-the-art electronic submission systems to ensure timely and accurate filings.
Compliance Management
We ensure all trial activities adhere to Good Clinical Practice (GCP) guidelines, prepare for and manage regulatory inspections and audits, and keep abreast of the latest regulatory changes to ensure compliance.
Ethics and Safety Reporting
We handle submissions to Institutional Review Boards (IRBs) and Ethics Committees (ECs) for ethical approval and manage the timely and accurate reporting of adverse events to regulatory authorities.
Regulatory Intelligence
Our team stays informed about global regulatory developments and trends, assessing how changes in regulations may impact your clinical trial and advising on necessary adjustments.