CLINICAL OPERATIONS SOLUTIONS

CLINICAL
TRIAL SUPPLY
SOLUTIONS

Business solution

KLIFO Clinical Operations Solutions navigates the unique complexities of individual clinical studies to ensure 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.

Klas Rådberg

VP

Klas holds a Master of Science degree and a PhD within Gastroenterology and joined KLIFO in March 2017. He has 16 years of experience from the clinical trial field where he has worked as project manager and clinical research director at big and mid-sized pharma companies as well as CROs. During these years, Klas has been actively involved in the delivery of more than 35 clinical trials/projects.

Expertise &
therapy areas

Expertise

KLIFO Clinical Operations Solutions offers flexible and best-in-class solutions including:

Phase I to IV trials
First-in-human (FIH) trials
Trials in Scandinavia
International trials in Europe and the U.S. under the auspices of PSN

Services

Development of Clinical trial synopsis
Development of Clinical trial protocol
Site feasibility and site selection
Submission of clinical trial application to authorities and ethics committees
Initiation of clinical sites
Interim monitoring of clinical sites
Closing of clinical sites
Development of Clinical study reports
Clinical project management
Pharmacovigilance
Data management and statistics
eClinical services
Development of eCRFs and CRFs
Medical devices
Clinical investigational plans
Sponsor oversight

Our expert staff

Sara Hedman

Senior Project Manager

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.
Thomas Eskildsen

Project Manager

Thomas holds a Master of Pharmaceutical Sciences and joined KLIFO in July 2018. He has 8 years of experience from big pharma companies working with project management within pharmacovigilance, endpoint adjudication, and clinical trial management (phases 1–4).
Camilla Marvig

Clinical Research Associate

Camilla holds a Master of Science degree in Pharmacy and joined KLIFO in December 2018. She has more than 5 year´s experience within Clinical Operations as a CRA, and has been involved in clinical trials from feasibility and initiation to database-lock and site closure. Camilla has worked within a range wide range of indications and has experience monitoring in all the Scandinavian counties.
Lone Roslev

Senior Clinical Research Associate

Lone has worked in the clinical research area for more than 25 years. She has worked for Nycomed, Lundbeck, Janssen Cilag. She joined KLIFO in August 2008 and works as CRA, CRA Training Manager and CRA Manager Lone enjoys to cooperate with the sites and to have the clinical trials performed according to protocol.
Helle Mirchandani

Senior Clinical Research Associate

Helle joined KLIFO in September 2017 and is a registered nurse, working within Cardiology for a decade. Helle has vast experience in clinical trials. She began on the investigational site in the role of both study nurse and coordinator and later moved on to a position as Clinical Research Associate at a global CRO performing both remote and on-site clinical activities for a variety of pharmaceutical companies.
Louise Helbo

Project Manager

Louise holds a Master of Pharmacy and joined KLIFO in February 2018 as Project Manager. She has more than 13 years of experience within clinical trial management in the pharmaceutical industry and biotech. During this period, she has gained operational experience with project management, monitoring and medical writing in phase 1-3 trials.

HIGHLY KNOWLEDGEABLE ABOUT CLINICAL TRIALS

HIGHLY KNOWLEDGEABLE ABOUT CLINICAL TRIALS

HIGHLY KNOWLEDGEABLE ABOUT CLINICAL TRIALS

DRUG
DEVELOPMENT
COUNSELLING

CMC
DEVELOPMENT
SOLUTIONS

REGULATORY
AFFAIRS
SOLUTIONS