Our Solutions to You

Ctimpsolutions understand the challenges sponsors or CROs face with Investigational Medicinal Products from manufacturing to CTA approval. This is why we believe that expert advice can help overcome these challenges and mitigate risks particularly for studies involving novel products. Whichever stage you are in your clinical trial, whether it's as early as pre-clinical work-up or as late as CTA submission, ctimpsolutions can work with you and optimise your IMP manufacturing and management strategy to ensure compliance with regulations and site set up processes 

Regulatory

With so many considerations and complexities throughout product development, having an effective regulatory strategy is paramount for optimising your chances of CTA approval. Ctimpsolutions can support you with

  • Scientific advice meeting preparation
  • Briefing pack with focus on pharmaceutical aspects of trials
  • GMP compliance of manufacturing
  • SOP writing/review
  • Product characterisation review
  • QC testing advice
  • Stability testing support
  • Shelf life assignment and extension
  • IMPD reviews

Training

With experience in providing training to clinical trial units and having taught on the MSc Clinical Trials postgraduate programme at UCL, ctimpsolutions can offer bespoke training to meet your needs. This includes:

 

  • IMP lifecycle and management
  • Supply chain mapping
  • GMP for IMPs
  • CTA documentation requirements
  • Pharmacy set up

Pharmacy

Having supported pharmacy teams across the UK with clinical trials set up, we can provide you with solutions to IMP management aspects of studies including:

 

  • Pharmacy manual writing
  • IMP storage, handling, dispensing and accountability
  • Pharmacy considerations when developing new products