Clinical Operations

Our experience in MENA region ensures high quality of clinical operations project management covering the four Phases in different therapeutic areas.

To get the best of a clinical study it’s crucial to build a partnership with a local CRO that has enough experience in this field and a pool of skills and talents that are able to handle your projects and deliver on time.

At KBP-Biomak, we know exactly what is needed and what should be done for a better study conduct including:

• Clinical Project Management

  • Feasibility
  • Selection of the best sites
  • Management of contract and investigator fees
  • Professional communication with Investigators, CRA meetings, Newsletters, …
  • While respecting International guidelines we take care of the clinical trial logistics management

• Clinical Site Monitoring

  • Close follow-up with sites to ensure a better patient recruitment and to develop a patient retention plan.
  • Monitoring activities for all types of visits
  • Preparation of essential study documents (ISF)

• Regulatory affairs

  • Submission to ethics committees
  • Submission to Regulatory Authorities