Clinical Research

We can support you from first-into-human studies right through to post-marketing surveillance. We can guide your product through the entire clinical trial process in accordance with ICH GCP guidelines. Whether you simply need advice on your study design, or a dependable partner to manage your whole drug development programme, Choice Pharma can help. Our research team is made up of highly trained and experienced staff who will work with you to achieve results within your timelines, offering a flexible, professional service that is tailored to meet your needs.

Our services include:

• Clinical development programming
  We can design drug development programmes, clinical trial protocols and case record forms, in collaboration with relevant regulatory authorities and Key Opinion Leaders, to ensure that your development plan yields the product profile you and your customers want.
• Clinical trials management
  We can manage the entire clinical trials process, from Phase I studies to Pharmacovigilance monitoring, including:
  • Management of clinical trial applications, including ethics committee approval processes
  • Feasibility studies, selection and inspection of suitable study sites, from dedicated Phase I centres to international multicentre sites
  • Recruitment of expert clinical trial investigators
  • Management, inspection and quality assurance auditing of Contract Research Organisations should you have already allocated your study programme.
• Post marketing surveillance
  Whether your risk management plan requires sentinel sites, registries, cohort studies or other post marketing activities, we can ensure that your post marketing commitments are fully and efficiently met.
• Clinical trial documentation
  We can undertake all the documentation and reporting of your clinical trial data to comply with regulatory requirements.
• Medical writing
  We can prepare and submit clinical trial reports, marketing authorisation dossiers and clinical papers, making sure your product profile is supported by ethical, accurate and consistent reference sources.