Study Monitoring and

Site Management

Our comprehensive clinical monitoring service is designed to ensure the integrity of your clinical trials. The Niche team of qualified professionals, each with extensive clinical research experience, delivers these services in strict adherence to ICH GCP guidelines and applicable regulations. Our clinical monitoring service ensures that clinical trials are conducted, recorded, and reported in accordance with the protocol, standard operating procedures (SOPs), and regulatory requirements.

Our team supports sponsors with study feasibility, site assessment, selection and activation activities, ensuring a streamlined and efficient process from start to finish.

Our team understand the intricacies of phase-development and therapeutic area speciality requirements, including: viral infections and infectious diseases, CNS diseases and pain, cardiovascular diseases, respiratory, CNS and rare diseases and a variety of oncology indications.

Expertise and Experience

Our Clinical Research Associates (CRAs) bring a wealth of experience across all phases of development to each project. The wide range of therapeutic areas we have worked in include – psychedelics, challenge trials, viral and infectious diseases, respiratory, CNS and rare diseases and a variety of oncology indications. Our experience allows our CRAs to handle the complexities of clinical trials efficiently and effectively, ensuring high-quality monitoring and support throughout the trial lifecycle.

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Frequently Asked Questions 
Our team has extensive experience managing clinical trial sites, acting as a dedicated liaison between sponsors and clinical sites across multiple therapeutic areas. We serve as the primary contact for sites, providing ongoing support and ensuring that site staff have the guidance they need without relying on the sponsor for every inquiry. 

By proactively monitoring site activities, we can quickly identify and address any issues, ensuring studies remain on track and compliant with regulatory standards. This approach fosters efficient communication, smooth operations, and reduces the burden on both the sponsor and site teams.
We provide risk-based site monitoring, with visit frequency determined by the study complexity and regulatory requirements. Our experienced CRAs conduct regular on-site and remote monitoring visits to ensure compliance and data integrity.
We conduct tailored site initiation visits and provide ongoing training sessions for site staff to ensure they are fully equipped to manage the study protocols and regulatory requirements throughout the trial.
Non-compliance issues are addressed through a root cause analysis, corrective and preventive action plans (CAPA), and additional training if necessary. We work closely with sites to resolve issues promptly and prevent recurrence.
Yes, we offer comprehensive site feasibility services, including evaluating sites based on their experience, patient population, and capacity. We use data-driven methodologies to ensure optimal site selection for your study.

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