Business solution
KLIFO Pharmacovigilance Solutions meets the increasingly complex regulatory requirements for drug safety to ensure optimal compliance with international and national regulations and guidelines.
Our team of pharmacovigilance experts offers flexible and effective solutions to meet your individual project needs – from early clinical development to marketed product support.
Klas Rådberg
Senior Strategic Advisor (Interim)
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.
Direct/mobile: +45 44 222 935
Email: moc.ofilk@grebdaaR.salK
Expertise &
therapy areas
Expertise
KLIFO Pharmacovigilance Solutions offers seamless delivery on all the safety needs for your products by helping you with a range of pharmacovigilance services, including:
Support as your Pharmacovigilance department from pre-clinical stage to marketed products
- Strategic advice
- Preparation and review of pharmacovigilance documents (Development Safety Update Report, Periodic Safety Update Report, Risk Management Plan)
- Perform oversight activities for outsourced services on behalf of sponsor
- Hosting of global safety database
- Preparation of safety documents for regulatory filing
- Liaison with authorities
Pharmacovigilance support for your clinical trial
- Input to clinical trial protocol and informed consent form
- Hosting of safety database
- Serious adverse events: Case handling, medical assessment and reporting
- Coding of adverse events, medical history and medication
- Safety surveillance and signal detection
- Host and provide input for Safety Committee
Pharmacovigilance support for your marketed product
- Act as QPPV
- Pharmacovigilance system master files
- Preparation of Periodic Safety Update Report
- PV agreement negotiations with partners and subcontractors
- Local PV for Denmark, Sweden and Norway
