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

Tina Hjorth

Director, Pharmacovigilance Solutions

Tina holds a Master in Pharmacy degree and joined KLIFO in March 2017. Tina has been in the pharmaceutical industry for more than 25 years and has held positions as a Clinical Research Associate, Drug Development Scientist, Lead GCP Auditor and several managerial positions at different levels. Tina has extensive clinical experience and broad knowledge of the disciplines involved in the global execution of clinical trial programmes.
Rikke Sevel

Clinical Research Associate
Sara Hedman

Project Manager
Jennie Wilborgsson

Clinical Research Manager

Jennie joined KLIFO in April 2018. She has 10 years of experience within clinical operations from pharma and CRO. During the last 5 years she has been working with risk-based approaches from risk assessment to ongoing risk management in clinical trials as well as with process implementation of risk based monitoring approaches.
Helle Mirchandani

Sr. 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.
Lone Roslev

Senior CRA

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.

CLINICAL
OPERATIONS
SOLUTIONS

DRUG
DEVELOPMENT
COUNSELLING

CMC
DEVELOPMENT
SOLUTIONS

REGULATORY
AFFAIRS
SOLUTIONS