Consulting

Drug Development

  • Consulting on development strategies for clinical pharmacology and clinical research for registration
  • Consulting on early Proof-of-Concept type developments to possibly provide an early no-go based on surrogate marker studies
  • Consulting on different study designs (e..g. pharmacokinetic / pharmacodynamic bioequivalence, non-inferiority trials, etc.)
  • Setting up development-, registration- and positioning strategies
  • Preparation of regulatory dossiers (Expert reports, IND filing, CTX filing, briefing books) for European and US authorities
  • Participation in End-of-phase II meetings with the FDA and other regulatory agencies (e.g. MCA and BfArm)
  • Consulting and implementation of population pharmacokinetic development in phase II and phase III trials
  • Consulting on concepts for shortening development times and rapid conduct of clinical trials

Medical Writing

  • Study reports
  • Protocol writing
  • Investigator brochure
  • Expert reports
  • Publications, abstracts and posters
  • Clinical summary reports

MedDRA

The Medical Dictionary for Regulatory Activities is in the process of being adopted by major regulatory authorities. The use of the MedDRA terminology generates questions and problems due to the complexity of the methodology and to the need to re-code old data.

To assist pharmaceutical companies to implement MedDRA, Swiss Pharma Contract makes available its experienced personnel in order to:

  • Coding data using MedDRA
  • Re-coding legacy data
  • Personnel training
  • E2B MedDRA

Biostatistics

  • Statistical analysis plan
  • Design of tables and listings
  • Statistical section of the protocol
  • Statistical report


Special in-house knowledge of the following therapeutic areas and development research activities:

  • CNS (Neurology: Alzheimer disease, general spasms, epilepsy, head trauma, stroke, migraine, multiple sclreosis, amyolateral sclerosis; Psychiatry: depression, schizophrenia, pain, bipolar disorder, aggression, social phobia)
  • Cardiovascular (Indications: hypertension, congestive heart failure)
  • Rheumatology (Indications: osteoid and rheumatoid arthritis)
  • Anti - platelet drugs (Indications: PTCA, acute coronary syndrome, stroke)
  • Respiratory (Asthma, inhalative devices)
  • Oncology (Biological response modifiers, supportive therapy to chemotherapy)
  • Immunology (Transplantation, allergy, atopical dermatitis)
  • Anti-glaucoma drugs
  • Topical formulations (Including nasal sprays, eye-drops, transdermal application systems)
  • Genitourinary
  • Medical devices
  • Life-cycle developments (e.g. slow release, i.v. and nasal formulations)
  • Gene technology products (e.g. Cytokines, vaccines)
  • Additional expertise available in our specialist network

    Please contact:

    Rolf Pokorny, M.D., M.Sc.
    Head of Clinical Research/Biometrics
    Lettenweg 118
    CH-4123 Allschwil , Switzerland
    Tel.: +41 / 61 / 487 24 00
    Fax: +41 / 61 / 487 24 01
    e-mail: rpokorny@pharmacontract.ch