Clinical Research Services
Clinical Research Strategy & Clinical Study Design
We can offer guidance, advice or direction whether from relatively simple comparative studies, more complex mulitple comparator studies and/or more esoteric matched paired analyses or historical based retrospective studies.
Clinical Research Protocol Design & Development
Clear and effective protocol design is key to generating clean effective data that are then able to support regulatory or marketing approvals quickly and without problematic re-design.
Case Report Form (CRF) Design
Whether using modern electronic data capture or hard copy data collection using our experience we can ensure the CARs are patient and subject appropriate. Clinical Study Management including liaison with Notified Bodies (e.g., BSi etc.) Competent Authorities (e.g., MHRA etc.) Ethics Committee Effective study management is vital to ensure that success of a study. We can ensure the approving authorities and study personnel are fully informed of the study progress at all times ensuring study progress and outcomes are successful.
Preparation of Study Reports and Product Evaluations
Successful data are only visible when data are reported promptly and accurately, our experience will allow you to ensure that your data are available and in a professional format to allow results to be disseminated quickly and accurately.
Support and Review of Clinical Publications
We can provide expert comment and insight into manuscripts in the expectation that the probability of publication can be significantly increased by ensuring the data provide verisimilitude to any peer review editorial board.
Clinical Trial Investigator / Site Management
Having had wide and in-depth experience at managing clinical study investigators and teams we are capable of managing a wide spectrum of personalities within any clinical research team.
Guidance to Start-Up and SME Organisations
It is essential that any new Start-Up or Spin-Off organisation has professional and knowledgeable advice upfront to ensure all resources are maximised and directed appropriately. Our experience will provide this expertise and allow start-up to flourish and grow as their product pipeline allows.
In-house management of CROs
Whilst CROs offer an excellent resource to conduct clinical research it is essential that a CRO managed project, whether it is wholly or only partially contracted out, is managed successfully by knowledgeable staff. We have experience of this process within the UK, EU, US and Asia Pacific regions.
Please contact us for support and questions in any clinical, non-clinical, safety toxicology and CMC related to products and for medical devices.