Clinical Research Support

Clinical trials are a crucial component of healthcare industry creating medicines, biologics, biosimilars, medical devices, in vitro diagnostics, vaccines, immunotherapies, etc. Clinical trials are the foundation of drug discovery. The evaluation of a trial’s conduct and the calibre of the data generated is made possible by the essential documents (both for interventional and non-interventional studies), which collectively show that the investigator, sponsor, and monitor complied with all applicable regulatory requirements and the standards of good clinical practice (GCP).

The entire process of developing a medicine includes organising a clinical study, drafting numerous documents before, during, and after the trial, submitting them to regulatory agencies, and reporting on safety. Research and development-related paperwork, pre-clinical support documents, clinical trial documents, quality assurance documents, regulatory affairs documents, safety documentation post-drug clearance, etc. are all necessary during this procedure. It is a monumental undertaking for any pharmaceutical company to prepare these records, which comprise significant molecule-to-product development information as well as information supporting drug lifecycle management (LCM). To assist pharmaceutical businesses in decreasing their workload, a committed team with knowledge of this drug development process is needed.

The clinical research specialists from the NeoCrest team are skilled at creating protocols, informed consent forms, clinical study reports, and investigator brochures for all stages of clinical trials and for all significant therapeutic areas. The documents adhere to international regulatory organisations’ standards and are compliant with ICH. The team also has experience writing clinical trial disclosure materials and abides by recently amended EMA, FDA, and Health Canada criteria for public disclosures.