pragmatic and resultdriven
Your professional partner in
clinical research management
Pennen Clinical Research Expertise is your trusted partner for support and management of clinical drug studies and medical device research.
Pennen Clinical Research Expertise is founded by Birgit van der Pennen. With over 18 years of experience in the field of clinical studies, Pennen Clinical Research Expertise can fulfill various roles during the start up, execution and close out phase of any research trajectory.
We excell in our ability to quickly adept to circumstances and implementing new topics as required.
We work for a wide variety of small and large CROs, central laboratories and academic hospitals located in The Netherlands or internationally.
Services
Sr CRA /Lead CRA
Ensuring that a Clinical Trial is conducted, recorded and reported in accordance with the protocol, Standard Operating Procedures (SOPs), Good Clinical Practice (GCP) and the applicable Regulatory requirements. This includes contact with the site and performing monitoring at international studies. Studies phase I to IV, evaluation, initiation and close outs. Mentoring/training of junior CRAs.
Study Start Up
Feasibility and quality visits, Site selection, Submission to and communication with the Central Ethic Committee and Independent Authority, CTIS, Site contact, contract negotiations, ICF preparation and amendments.
Project Management/ Clinical Team Manager
Operational project management and line manager to allocated (unblinded) study team (Monitors, Site Managers, CTAs ). Proactively identify, resolve or escalate risks and/or issues. Ensuring that study team members are trained to perform their assignments. Organizing and facilitating project team meetings. Developing, reviewing and revision of project documents. Investigator identification and selection. Monitoring visit report review.
Therapeutic Areas
Cardiology
Hematology
Oncology
Pediatrics studies
Cystic fibrosis
Dermatology
Lung diseases
Diabetes
“When it comes to working in Clinical Trials, I believe the whole is greater than the sum of its parts”
“When it comes to working in Clinical Trials, I believe the whole is greater than the sum of its parts”
about
Birgit van der Pennen
After obtaining a PhD in Cardiovascular research, Birgit started in September 2007 as a CRA and transitioned into Trial Manager, Project Manager, Study Start up Specialist and Clinical team manager. Birgit gained experience in phase I to IV studies, from feasibility to close out visits. Also early development, innovative study designs, real world data and investigator initiated studies.
Study Start Up, including site start up, contract negotiations and communication with ethics committees and regulatory authorities. Therapeutic experience: Diverse with extended experience in Cardiology and Oncology.
Birgit is a pro-active team leader with strong communication and problem solving skills. She is excellent in working in teams, because she is able to level with all team members and stakeholders that all have different angles. When it comes to working in Clinical Trials, Birgit believes that the whole is greater than the sum of its parts
WHAT PEOPLE SAY
Get in touch
Contact information
Birgit van der Pennen
Pennen Clinical Research Expertise
De Twee Sluizen 9
2924 BZ Krimpen aan den IJssel