Our Services

Our services for academia, pharmaceutical and biotechnological companies

We are an academic cancer research institution. Our services are focused on supporting academic hospitals and small to medium sized pharmaceutical companies. We establish a long-term partnership, in which we provide our partners with complete solutions for the development of innovative drugs, starting from assessing the potential of new therapies, the conduct of affordable and effective pre-clinical and clinical trials to regulatory approvals or other exit strategies. Our strengths emerge from the unique composition of:

  • own phase I/II units embedded in oncology hospitals,
  • a large network of more than 500 medical cancer centers worldwide,
  • tight collaboration with international experts and key opinion leaders, covering all fields of oncology,
  • and our CRO facility with profound expertise in all processes required for study conduct, regulatory approval and market access.

 

We understand the special challenges scientists and smaller biotech companies are facing and our services listed below are indicative of this:

  • Complex clinical trials
  • Product positioning
  • Project planning and project development
  • Drafting of clinical trial protocols and statistical analysis plans
  • Consulting on trial planning and translational research projects
  • Application for research funding and grants
  • Drafting of relevant trial documents (synopsis, informed consent forms, both electronic and paper based CRFs, working instructions and operating procedures etc.)
  • Patient recruitment
  • Patient treatment on our own phase I unit
  • Consulting on market launches and market authorization
  • Consulting in benefit-related assessment processes (AMNOG, GBA)
  • Conduct of all regulatory processes (IRB’s, federal and regional authorities, incl. obtaining and pre-checking of contractual partners’ relevant documents)
  • Implementation and coordination of trial related working and operating procedures (e.g. pharmacy, pathology, laboratory)
  • Coordination and bio-banking for translational research projects
  • Pharmacovigilance, safety reports, coordination of data/safety monitoring boards
  • Statistics, incl. comprehensive support and consulting on sample size calculations and analysis
  • Editing and publication of trial results