NON-CLINICAL

NON-CLINICAL

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Basic principles

From Probability to Success

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. Optimized non-clinical development is an important success factor for later clinical development. 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

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CRO Management

The last few years have seen tremendous consolidation in both the pharmaceutical and contract research industries. The impact among pharma companies has created a heightened demand for productivity. Properly designed CRO Collaboration opens capabilities in various functions like the following:

HIGHLIGHTS

  • Pharmacovigilance
  • Medical Writing
  • Statistical Programming
  • Site Management
  • Regulatory Affairs
  • Regulatory Operations
  • Biostatistics
  • Data Management
  • Translational Medicine
  • Medical Affairs
  • Clinical Monitoring
 

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Remote Image Analysis

When researchers start to collaborate over distances with imaging centers, using diagnostic services over internet connections the bandwidth and computation power easily exceeds the capabilities in remote areas.

HIGHLIGHTS

  • 3D organotypic culture models
  • Microplates
  • Automation and liquid handling
  • 3D imaging
  • 3D image analysis
 

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SOP Change Control

Life science organizations developing or manufacturing pharmaceutical products will typically create, maintain and execute large amounts of standard operational procedures (SOP). The solid change control and deployment of SOPs are a fundamental to achieve compliance excellence.

Properly designed Standard Operating Procedures include step-by-step instructions as well as the following:

HIGHLIGHTS

  • Objective (Purpose)
  • Scope
  • Responsibilities
  • Accountability
  • References
  • Task Instructions (Procedure)
  • Documentation
 

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