An integral phase of clinical research providing clients with accurate high end quality documents ready for global regulatory submissions. The team at MC is specialized in data conversion from complex crude paper formats to highly curated inter-intra linked ‘just a click away’ e-formats. Our core expertise includes preparation of pre-trial & post-trial documents and conversion of patient related data to organized electronic report formats matching scientific and regulatory standards.
Documents at pre-trial and pre-database lock:
- Preparation of SOPs, Clinical Study Protocols, Informed Consent Forms, and data management including designing of CRFs. We also have experience in developing e-CRF platforms based on client requirement suiting the nature of trial
{Database lock – in co-ordination with research monitors at site}
Documents at post-trial and post-database lock:
- Clinical Study Reports [Compilation of CSR and appendices in submission ready formats (eCTD formats)]
Independent documents:
- Investigator Brochure and Patient Narratives
- Safety Reconciliation
- Protocol and informed consent documents
- Clinical summary and clinical overview documents for e-CTD (electronic common technical document) submissions
- Non-clinical summary and non-clinical overview documents for e-CTD submissions
- New drug application (NDA) and investigative new drug application (INDA)
- Development safety update reports (DSUR) and periodic safety update reports (PSUR)
