Clinical Operations

Flexible and scalable solutions

Our experienced Clinical Operations Team can provide flexible and scalable solutions to manage any clinical trial whether it be Risk Based or Decentralised. We have extensive experience across all phases of clinical research and in all therapeutic areas with a rich history in rare disease, oncology/heme-oncology and infectious diseases. Our global reach, highly skilled experts, and industry leading systems, processes, and training, offer seamless quality project delivery.

Our ethos

We realise that Clinical Operations services are crucial in the delivery of a clinical trial and are proud to build our relationships on transparency, innovation, and insight based on real study experience.

Quality in-house delivery

From the first interaction with our clients we assess the protocol design and risk; and plan robust feasibility.  With a stand-alone Feasibility, Start-Up and Legal Team dedicated to clinical research, we can fast track site identification and start-up and reduce the overall time from protocol design to First Patient First Visit.

We understand that all of our client’s needs are different, therefore we tailor our services based on individual requirements.

Our full list of services are as follows:

• Site identification and feasibility
• Detailed protocol review, assessing risk & operational challenges
• Long standing relationships with Patient Advocacy Groups, who we engage for our clinical programs, ensuring we have the most appropriate study design and materials which fosters improved Ethical Review Timelines and patient understanding/engagement
• Site selection and qualification visits
• Submission and approvals from Ethics Committees and Institutional Review Boards
• Managing and planning subject recruitment
• Quality focussed analysis of all sites to ensure they are capable of managing the clinical study and are GCP and inspection ready
• Initiation, interim monitoring, and study closure visits
• Essential document collection, review and processing
• Good Clinical Practice monitoring, including motivational and training visits
• Source documentation review, CRF review and query resolution
• Accountability for all study documents and materials
• Study specific training to site personnel
• Review of Investigational Product accountability and storage
• Full safety review of all subjects
• Managing and training on protocol deviations
• Monitoring study progress
• Database lock and study close out