transparency in clinical trials
It is the moral and scientific responsibility of all the stakeholders (patients, caregivers, healthcare providers, payers and regulators) involved in the conduct of clinical trials to honor the significant contributions of the clinical trial participants. One of the primary objectives of clinical trial research is to ensure the safety and well-being of the study participants, with a broader implication on sharing trial results to advance the field of medicine. Despite increasing public and regulatory pressure including a legal mandate to disclose clinical trials results, the compliance rate is still low. Some of the key reasons for this low compliance could be lack of awareness among academia, industry and journal editors of the legal responsibility to disclose clinical data, inadequate resources, funds, lack of enforcement etc.
We at CRC Pharma, provide services, technology, and expertise to meet evolving transparency and disclosure requirements by the sponsors. Our team is highly qualified and experienced in clinical trials development and implementation across various therapeutic areas. They, thus, have impeccable capabilities to provide reliable solution for clinical trials disclosures.
Some of our members are also contributing as editorial experts to review lay language summaries with one of the most admired and respected non-profit organization engaged in recognizing public and patients as partners in the clinical research process.
We work with our clients to satisfy their needs as per regulations in US (FDA, NIH) and Europe such as the EFPIA/PhRMA Principles for Responsible Clinical Trial Data Sharing, European Union Clinical Trials Regulation, EMA policy (0070) for data transparency amongst others.
Key service are :
- Anonymized clinical documents (prospective and retrospective clinical data)
- Individual patient data anonymization
- Writing simple, easy to understand clinical lay language summaries (CLLS)
- Review of the CLSS, to authenticate its compliance with the regulations
- CSR redaction (with more focus on redaction PPD, CCI )
- Supports clinical protocol registrations and disclosure of study results