SECURE, RELIABLE, AFFORDABLE WITH NO HIDDEN COSTS.
Once a clinical trial is complete and reports are finalized, we can provide the Sponsor with the Trial Master File. Different regulatory jurisdictions have distinct requirements on the archiving of the Trial Master File and data collected during the clinical study, with some regions requiring archival for a minimum of 25 years.
British BioMedicine Clinical Trials (BBMCT) offers archiving as part of clinical trials to comply with regulations, taking the burden off you to hold these hard-copy documents securely for long periods of time. We use a globally-recognized, third-party vendor to keep your records securely for years to come.
As per the New Drugs and Clinical Trial Rules (2019) and Good Clinical Practice Guidelines by CDSCO, all essential documents pertaining to a clinical trial must be archived. It is the responsibility of the sponsor to ensure that the documents and trial supplies are archived for at least three years after the completion of the trial, or submission to the regulatory agency; whichever is later. In addition to essential documents and trial supplies, the sponsor may have specific archival policies pertaining to each study and hence the archival plan must incorporate these specifications as well. For instance, the sponsor may retain the documents for a longer duration. Archival is a key requisite to ensure post-trial monitoring, evaluation, and to facilitate further research.
British BioMedicine Clinical Trials (BBMCT). Plz visit www.bbmclinicaltrials.com
In certain instances, the regulatory authority and/or the ethics committee may recommend a timeframe for archiving of documents for a clinical trial, at the time of granting an approval.
The regulatory agency and/or the sponsor may request the investigator to archive certain essential documents for longer than the specified period. The sponsor should notify the investigator / institution in writing, when the trial related documents are no longer required to be retained. The investigator should ensure that these archived documents have restricted access and are secured in a location that maintains their integrity.
We at British BioMedicine Clinical Trials (BBMCT), have established necessary Standard Operating Procedures (SOPs), infrastructure, and a trained team to serve our clients in terms of archiving Clinical Study Records as per relevant guidelines.
BBMCT offers Archival Service to:
✔️Pharma Companies
✔️ Hospitals
✔️ Medical Devices Manufacturers
✔️ Ayurvedic And Nutraceutical Companies
✔️Cosmetics And FMCG Companies
✔️Agricultural And Food Processing Companies
✔️ Doctors
British BioMedicine Clinical Trials (BBMCT). Plz visit www.bbmclinicaltrials.com
