About ClinPharm Services

ClinPharm Services was founded in 2013 by Tom Janssen, professional with 35+ years of CRO and Industry experience in Clinical Pharmacology, Biopharmaceutics, Phase I Clinical Development, Bioanalysis, Regulatory Affairs and Medical Writing.

ClinPharm Services offers a wide range of services to the Pharmaceutical and Medical Device Industry, based on the comprehensive experience, skill, and knowledge gained over the years, with meeting or exceeding the client's expectations and needs as the ultimate goal.  

Prior to founding ClinPharm Services, Tom was responsible for creating and running a state-of-the-art phase I clinical research facility with on-site biomarker clinical laboratory at Johnson & Johnson Pharmaceutical Research & Development, and held the position of Director and Department Head of the Clinical Research Unit for almost 11 years. At the time he left the Belgium based research unit, the department was well established and recognized within Belgium and Johnson & Johnson as a center of excellence for the execution of first in man studies on small molecules and biologics alike. 

 

In-depth experience in phase I clinical research was attained during the preceding 15 year carrier at a CRO in the Netherlands (which followed a 5 year training in the field of pharmacokinetics and bio-analytics at the University Hospital of Nijmegen, the Netherlands), where the position of Study Director, Head of Phase I Clinical Research and Business Development was held for 15 years. Medical writing, expert input as clinical pharmacologist, regulator compliance, and regulatory affairs were part of his comprehensive responsibilities. 

Since having offered his expertise and dedication as an independent consultant,  Tom has successfully completed close to 200 projects in the area of writing phase I clinical study concepts, expert reports, CTD modules 2.5 and 2.7, expert reports in the area of BCS classification,  bio-waivers, and ethnic differences.

Development of phase I clinical study concepts and full study protocols, bio-analytical study plans and pharmacokinetic analysis of raw study data (using Certara Phoenix WinNonLin) are part of the services offered

Other services offered are quality control and full reanalysis of pharmacokinetic studies  (starting at the study plan level and raw data) conducted and reported by third parties.

Review and correction of clinical and bio-analytical study protocols and study reports are among the services provided as are addressing queries from Health Care Authorities around the globe. 

Delivering high quality advise, documents, expert opinion, without requiring significant input and guidance from the client, and delivering on-time and on-budget, is what's Tom stand for.

 

© 2020 by Tom Janssen, ClinPharm Services.