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, S2M Lifescience 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.
Patient Safety Narrative (PSN) is written for all phases of a clinical trial, whether conducted on healthy volunteers or patients with disease or condition under investigation. PSN is written in case of Serious Adverse Eents (SAEs) and Adverse Events (AEs)leading to permanent discontinuation from the trial and in case of casualty. PSN is an indispensible component in clinical study reporting from the regulatory viewpoint. As per ICH E3, the PSN should include the following:
Label preparation and updates— Core Data Sheet (CDS), US Package Inserts (USPI), Summary of Product Characteristics (SmPC), and Preparation of Local Product Documents (LPDs)