Clinical Trial Support Services

MODEPHARMA is dedicated to the provision of high-quality supporting services for non-commercial/small pharma clinical trials including:

Clinical Trial Setup and Management

To help you with the setup and running of your trial, we can provide full assistance with the following:

  1. Site evaluation and selection
  2. Trial Master File / Site File compilation including the creation of Case Report Forms
  3. Protocol evaluation and/or writing
  4. Investigator Brochure development
  5. IMP Dossier (including the quality data for the IMP) development
  6. Regulatory and Ethics submissions
  7. Site Initiation
  8. Clinical trial organisation and management
  9. Site Monitoring
  10. Site Closeout
  11. Contract Research Organisation (CRO) and support services evaluation and selection
  12. GCP and PVG auditing

For further information on any of the above services please contact us .

Randomisation

MODEPHARMA can provide a randomisation list for your trial, as well as offer an online randomisation service using a validated system, with full audit trail. Using this system, you can be certain your patients are stratified using the correct data, know when your patients are randomised, and be confident that blinding is assured.

The service is setup and run by the Mental Health and Neurosciences Clinical Trials Unit (MH&N CTU) which specialises in the design and conduct of randomised controlled trials in the field of mental health and neuroscience, including behavioural trials in all disease areas.

The Mental Health and Neurosciences Clinical Trials Unit helps research teams throughout the country carry out clinical trials safely and to a high scientific standard, and offers a range of services to help ensure the results are accurate and credible. The Unit’s services are available to researchers based across the UK. Full details about the Unit’s services can be viewed here.

Pharmacy Standard Operating Procedures (SOPs) for Clinical Trials

MODEPHARMA aids NHS pharmacy departments in the development, writing and implementation of Standard Operating Procedures (SOPs) for the handling of clinical trial medication. Full details about this service can be viewed here.

GCP/PVG Auditing and Mock Inspections

We offer a GCP/PVG auditing service as well as mock GCP/PVG inspections. This service is intended to ensure your infrastructure for clinical trials is robust and in preparation for MHRA inspections.

GCP/GMP/IMP Training

Click here to view our training services.