We know that a robust clinical and regulatory strategy delivers long-term value and confidence to your idea or concept. consult2deliver limited have extensive knowledge and experience of phase I clinical studies (Pharmacokinetic/Pharmacodynamic). We help companies develop clinical strategies, outline clinical programmes and given input to protocol development (Phase I-IV).
We can collaborate to create
- Investigator Brochures (IB)
- Investigational Medicinal Product Dossiers (IMPD)
- Bibliographic reviews to validate idea/concept
- Clinical strategy in line with regulation
- Clinical strategy with/without scientific advice
- Formal project planning
- Analysis of data from clinical studies (I-III) to confirm alignment with clinical strategy
- Study design and protocol preparation
- Review clinical study reports (CSRs) to be fit for purpose
We work with a variety of clinical professionals who can help advise, shape and develop a study outline for your product development.