Process and Methodology

The company supports Key Opinion Leaders, District General Hospital consultants and General Practitioners across East Anglia and Yorkshire. Our objective is to provide the infrastructure that enables the physician to conduct clinical research, managing all aspects of the work, including the relationship with the Trust and the Sponsor company. Our primary relationship is with the physician, not the Trust or the Sponsor company.

Our service starts with feasibility to identify suitable sites and, where requested, help fine-tune the protocol. Following site selection our Business Development Manager will facilitate budget and contract negotiations with the sponsor company and site. In parallel, our Start-up Group will manage the local ethics and R&D approval process. Throughout the entire study, our Clinical Operations Manager and team of Research Nurses provide dedicated hands-on support to our Investigators.

We offer wide ranging support at all stages of the trial, bringing our experience to bear to ensure the smooth running and success of the trial.

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Research Nurses – the engine of the company

Our success is a direct result of the quality and performance of our Research Nurses. Not just study site co-ordinators, they have a hands-on role in all aspects of running a study including patient identification, recruitment and study procedures. They become part of the physician’s team and work closely with the specialist nurses.

Summary of our Research Nurses:

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Study Management Services

Our Study Management team, led by our Clinical Operations Manager, ensure the smooth set-up and rapid delivery of study objectives. They also have the local knowledge and expertise to manage all aspects of the trial process including:

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Project Support

We offer the following three levels of Project Support:

Central Administrative Support

Our central administrative office in the outskirts of Cambridge co-ordinates trial activities across our sites, acts as a single-point of communication and provides a professional and proactive approach to study management.

Site Support

Instead of relying on existing overstretched clinical staff we provide study specific support via our Research Nurses. They form an integral part of the clinical research team and work in collaboration with the Investigator, relevant hospital departments and our Sponsor. They actively manage all aspects of the study, including management of essential trial documents, patient recruitment and the provision of on-going study assistance to the Investigator and Sponsor.

Rapid recruitment of patients and their compliance is achieved by our Research Nurses' committed approach to patient identification and strong patient management skills. This strategy ensures data collection of the highest quality, and allows us to consistently achieve our recruitment and quality targets.

Study Support

Stage 1 - Protocol Assessment
Fundamental to the feasibility process are our Research Nurses. Assigned to specific investigators, they have established an excellent understanding of each site, the investigator's team and their patient database. We utilise their knowledge to provide our Sponsors with information that better enables them to make protocol and site selection decisions.

Stage 2 - Study Preparation
Our Study Management team establishes and maintains a level of communication with our Sponsors to ensure all study related matters are discussed and agreed up-front. Particular attention is made to study timelines, recruitment updates and action plans. Above all, we are keen to ensure our Sponsor's key performance indicators are achieved, if not bettered. Managed centrally by Study Management, our team of Research Nurses proactively prepare for study start-up by identifying suitable patients, obtaining local regulatory approval and liaising with relevant departments.

Stage 3 - Study Conduct
Study Management monitors patient recruitment and progression throughout the study, provides regular study update reports and attends study review meetings and monitoring visits with the Sponsor to ensure the timely delivery of study objectives. Action plans are promptly produced and implemented to address issues such as protocol amendments.

Stage 4 - Study Close-Down
Our Research Nurses work closely with Sponsors to ensure data queries are resolved quickly and fully. We perform a complete financial reconciliation of study finances to ensure there are no outstanding discrepancies. We encourage our Sponsors to discuss performance and share feedback throughout the study. Finally we liaise with our Sponsors to provide investigators and patients with study results.

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Scientific Advisory Group

Our Scientific Advisory Group is made up of internationally recognised opinion leaders who are located within the Universities and Teaching Hospitals of Cambridge and Sheffield.

The Group has 4 main functions:

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