Clinical Study Management

At Niche we are committed to the success of each client’s clinical programme. Our highly experienced project managers ensure that your project meets study timelines and is conducted to rigorous standards.

We can provide a tailored service to support preclinical and clinical researchers bringing compounds to trials in humans, by facilitating trial setup, 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 by providing 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 sheets 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
• Study monitoring
• Site management
• Creation and management of trial master and site files
• Archiving at both the sponsor and investigator site
• Organisation of investigator meetings