Data integrity for non-clinical documentation

From probability to success 

An optimized non-clinical process is a key factor in clinical development's eventual success. For researchers, data analysts, project/vendor managers, and report writers, it's vital to stay on top of the documentation throughout the process and provide the necessary later phase deliverables for the eTMF. By staying organized, professional and diligent, these researchers will be helping to ensure that the drug development process is conducted to the highest standards.

The non-clinical (or pre-clinical) development phase primarily aims to identify which candidate therapy has the greatest probability of success, assess its safety, and build solid scientific foundations before it comes to testing humans.

The non-clinical development process starts in parallel with research activities, and non-clinical testing is conducted throughout all phases of drug development to assess the safety profile and pharmacokinetic and toxicokinetic characteristics of drug candidates.

Data analysts, project and vendor managers, and report writers need to stay on top of all documentation along the process and need to deliver in later phases and into the eTMF for further reference.

• Non-clinical / Pre-clinical Project Management
• Planning and Tracking along Drug Development Plans
• Management, documentation and reporting of non-clinical programs, projects, studies (GLP) e.g. ADME, PK/TK & Tox, including CRO selection
• Pharmacokinetics and Toxicokinetics (PK/TK) (GLP)
  Preparation of Non-clinical Regulatory Documentation & Reports (IND, IMPD, IB)
• Non-clinical (Preclinical) Process Consultancy