Business solution

KLIFO Clinical Operations Solutions navigates the unique complexities of individual clinical trials to ensure the shortest possible development times, reduced risks and constrained costs.

Our experienced staff leverage their in-depth expertise to create scalable and flexible solutions to meet your specific needs.

Randi Rahbæk

COS Nordic

Christoph Kapitza


Senior Director, COS Nordic & Managing Director, COS DACH

Randi holds a MSc in Pharmacy and joined KLIFO in January 2021. She has more than 20 years of experience within people leadership, drug development and clinical operations excellence and has been with large, mid-sized and small pharma companies as Director for Trial Operations and Business Support.

During her career, Randi has been operational responsible for planning and execution of global clinical development programs from early stage to the post-approval phase.

Direct/mobile: + 45 44 778 704
Email: moc.ofilk@keabhar.idnar

Dr. Christoph Kapitza joined KLIFO on 1 August 2022 and brings more than 25 years of research experience in the development of drugs, devices and drug-device combination products. He has a proven track record of successfully executing drug development strategies and has held several leadership positions in the pharma industry. Dr. Kapitza has been Principle Investigator in approx. 90 early and later phase studies, and he has been a consultant in relation to clinical development plans (phase I through to post-marketing studies) for several top global pharma companies.

Direct/mobile: +49 160 765 1092
Email: moc.ofilk@aztipaK.hpotsirhC

Expertise &
therapy areas


KLIFO Clinical Operations Solutions has a strong track record of conducting early and late stage clinical trials in an efficient and flexible manner within various therapeutic areas, including in particular oncology, gastroenterology and CNS.

We operate from the four offices in Denmark, Germany, Sweden and the Netherlands in a global setting with local support from well-established and long-lasting collaborators across the world.

CRO services (clinical trials):

  • Clinical project management
  • Medical writing
  • Clinical trial application-submissions
  • Feasibility and site selection support
  • Clinical and medical monitoring
  • eTMF service (Veeva Clinical Vault)
  • Pharmacovigilance incl. data safety monitoring boards, safety surveillance and medical coding
  • Biometrics
    • Data management (eCRF setup and review, data review and query resolution, medical review)
    • Biostatistics (from trial design to statistical output in CDISC, SDTM and ADaM standard, randomization)
    • Pharmacokinetic calculations and reporting
  • Clinical trial supply service incl. IRT

KLIFO Clinical Operations Solutions also offer advisory and consultancy services to fulfil specific tasks or to fill competence and resource gaps on short- or long term basis.

Advisory services for pharma-, and biotech companies:

  • Strategic advice
  • Clinical project leadership and management
  • Outsourcing management: CRO and vendor feasibility, evaluation, selection and qualification
  • Sponsor oversight – advice and/or support
  • Facilitation of risk assessment- and management workshops and oversight
  • Medical writing (Investigator’s Brochure, synopsis, protocol, report, posters, abstracts and scientific articles, Annual Reports (DSUR/PSUR)etc.)
  • Biostatistics support (e.g. adaptive or conventional trial design, sample size calculation, CDISC advice, SAP, CRO oversight)
  • Data management support (e.g. CDISC CDASH standard, eCRF/ePRO design, pooling of data)
  • Provision of eTMF service in KLIFO clinical vault (hosted by Veeva) incl. setup, maintenance and oversight services during trial conduct and eTMF archiving after trial closure
  • eClinical systems (audit and qualification, system validation with GAMP5, life cycle management)

Our expert staff