Clinical project management

We are committed to the success of each client’s clinical objectives. Our clinical project managers will ensure that your project meets study timelines and is conducted to rigorous standards.

We can provide a tailored service to support pre-clinical and clinical researchers bringing compounds to trials in humans, by facilitating trial set-up, providing assistance in preparing sites for clinical trials and ensuring that regulatory and ethical requirements are met.

We can fill gaps in expertise or resources in the form of a full service package from concept to final study report, or by providing individual services as and when they are needed.

  • Assessment of potential sites
  • Coordination and preparation of ethics and regulatory documents and their submission
  • Protocol writing and review
  • Development of patient information and consent forms
  • Preparation of study reference manuals
  • Preparation of standard operating procedures for the conduct of trials
  • Organisation of CRF development and data management services
  • Coordination of clinical trial medication supplies and labelling
  • Organisation of laboratory sample analysis
  • Clinical governance of ongoing studies
  • Site management
  • Creation and management of trial master and site files
  • Archiving at both the sponsor and investigator sites
  • Organisation of investigator meetings

 

 
 

t: + 44 (0)20 8332 2588
f: +44 (0)70 4306 5098
e: info@niche.org.uk

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