Running the appropriately designed, regulatory and IRB (ethical) approved, clinical trial is vital for the success of your organisation. Our extensive experience in all areas of clinical trial design, set-up, close-out and write-up gives you the opportunity to outsource all or a portion of your requirements resulting in improved cost effectiveness. We, in effect, become an extension of your clinical department.
- Protocol design and writing – we can help in all areas from review of your draft protocol to writing the whole document to enable an ICH GCP conducted trial. Our extensive expertise and experience in designing early phase Proof of Concept trials in the wound care and anti-scarring area could cut millions from your total clinical development budget.
- IRB approval – we can submit and/or facilitate submission to any chosen IRB site to accelerate the start of your trial.
- Regulatory – we can facilitate and manage your regulatory submission, giving clinical support to the submission.
- Assist in CRF design – the capture of all the necessary procedures, including AEs and SAEs can be facilitated by the design of the correct “user-friendly” CRF.
- Trial set-up – with our extensive experience and contacts we can do everything from the “set-up meetings”, Investigators’ meeting, contract trial sites to ensure ICH GCP compliance and so facilitate a smooth progress to the market. Trial write-up – after a successful trial, database and statistical analysis we can close the process with our expert medical writers to present you with a document that can be “pasted” into your (e)CTD for regulatory approval.