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Regulatory Compliance

CenterWatch

CenterWatch has developed a multitude of procedures to maintain pharmaceutical regulations and guidelines.

Standard operating procedures for the conduct of clinical research

Standard operating procedures for the conduct of clinical research has been created to help clinical research sites maintain rigorous standards in a world of declining resources.

The template has been expanded to include more procedures to assess study feasibility, recruit subjects and ensure regulatory compliance. It is based on the Code of Federal Regulations and GCP Consolidated Guidelines.

Policies and standard operating procedures for the institutional review board

This type of procedure is an efficient way for IRBs to record policies and processes which imitate their organisation’s philosophies, standards and innovations, while continuing to comply with federal regulations.

The SOP template is based on the Code of Federal Regulations, guidance and ICH/GCP Consolidated Guideline and the Association for the Accreditation of Human Research Protection Program’s (AAHRPP) standards for human subject protection.

Standard operating procedures for good clinical practice by sponsors of clinical trials

The standard operating procedures for good clinical practice by sponsors of clinical trials, was developed to help pharmaceutical and biotechnology companies maintain the quality performance and ethical conduct of clinical trials, while adhering to U.S. federal regulations.

The template contains 30 procedures addressing all good clinical practice requirements. It is based on FDA regulations and ICH guidelines.

Standard operating procedures for good clinical practice by sponsors of medical device clinical trials

This guide offers detailed standard operating procedures to address specific FDA regulations and requirements which medical device research practices must adhere to. Organisations that sponsor clinical research on new medical devices must implement procedures that comply with good clinical practice guidelines, as well as federal regulations.

Contact details:
Emily Greenwill

Phone: 617 948-5152
Email: emily.greenwell@centerwatch.com

Quick Contact Regulatory Compliance