To ensure transparency in clinical research, increase awareness among the public about the ongoing clinical trial, and comply with stringent mandatory regulatory requirements, the European Federation of Pharmaceutical Industries and Association (EFPIA), the European Medicines Agency (EMA) and the Pharmaceutical Research and Manufacturers of America (PhRMA) have made it clear that the sponsors of clinical trials have to publish the data in clinical trial registries like ClinicalTrials.gov. In India, the entry should be in the Clinical Trials Registry - India (CTRI, ctri.nic.in) database. Moreover, the clinical trial outcome should also be published in peer reviewed journals. These tasks seem to be Herculean for the sponsor company. However, Reseapropharma has a strong track record in medical writing and communication to support our clients in public disclosure and transparency of clinical trial data. We offer the following services.
- Reporting the result of the clinical trial (EudraCT, ClinicalTrial.gov, PharmaCM)
- Registration of Protocol Summaries (e.g. ClinicalTrials.gov, PharmaCM and rest of the global registries)
- Layman Summaries (for patients who participate in the study)
- Clinical Study Report Redaction for public disclosure