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.
Sara Hedman Christoph Kapitza
Sara joined KLIFO in December 2018 and has 15 years of experience from pharma, working with global project management within clinical trial management (phase 1-3) and clinical trial supplies. She is especially experienced within early clinical development (phase 1a-2a) and has managed trials within many different therapeutic areas in Europe, US and Asia.”
T: +46 708 708 084
Email: moc.ofilk@namdeH.araS
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.”
T: +49 160 765 1092
Email: moc.ofilk@aztipaK.hpotsirhC
Expertise &
therapy areas
Expertise
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)
