Expertise

We provide more than 40 years of experience in the clinical research industry.We have seen a wide range of indication and taken over roles at CROs, technology vendors and in the life science industry.
maxclinical can reach out to a network of experts in the areas of

  • computer system validation (CSV)
  • quality and audits (specialist auditors for computerized systems)
  • process and business analysis
  • clinical data management and data analytics
  • clinical operations and clinical trial management

Selected projects

eClinical Consultancy

  • Development of a strategic innovation and digitization strategy
    • Biotech Company
    • CRO
    • Pharmaceutical Industry
  • Selection and implementation of an eTMF (electronic Trial Master File)
    • Biotech Company
    • CRO
    • Pharmaceutical Industry
  • Selection and implementation of a CTMS system (clinical trial management system)
    • Biotech Company
    • CRO 
  • Selection and implementation of an EDC System (electronic data capture)
    • Biotech Company
    • CRO
    • Pharmaceutical Industry 
  • Implementation and global roll-out of a LMS (Learning Management System)
    • Pharmaceutical Industry
  • Implementation and operation of a clinical trial investigator portal
    • Biotech Company
  • Development of a system for quality risk management in clinical trials
    • research project funded by the federal republic of Germany
  • Business and Technology Consultancy for
    • adaptation of an imaging system for the requirements of a global pharmaceutical company
    • business analysis for eClinical technology vendors
      • EDC
      • eTMF
      • CTMS
    • implementation of CRM technology for eClinical vendors and CROS

eClinical operations

maxclinical provides eClinical services. maxclinical performs the vendor contracting and management and delivers 3rd party cloud based IT solutions for its clients. You – our client – can focus on your business need, maxclinical delivers the suitable technology:

  • operation of a data room for secure document exchange
  • operation of EDC systems for
    • clinical trials
    • clinical registries and NIS (non-interventional studies)
    • medical device trials
  • operation of eTMF systems for
    • clinical trials
    • medical device trials
  • system management for
    • clinical trial investigator portals
    • eTMF
    • EDC
    • CTMS