Our Expertise

Our expertise in early drug delepopment and drug safety. Contact us

With long-standing experience in early drug development and drug safety, we support your projects, scientifically driven and target oriented.

We work thoughtfully. We adhere to timelines. We think from a solution perspective. Quality and regulatory compliance are of paramount importance. We communicate carefully, appreciate teamwork and respect culture and diversity.

Team

Katharina Erb-Zohar, MD, PhD

Founder and owner of clinphase®, is a board-certified Clinical Pharmacologist with in-depth knowledge and 30+ years of experience in clinical pharmacology and clinical drug development and 20+ years of experience in drug safety/pharmacovigilance. Her work is focusing on early drug development, including translational aspects and proof-of-mechanism or proof-of-concept clinical trials, and safety of medicinal products. She is being supported by administrative assistance and free-lancers.

As surplus she is trained in Systemic Coaching which eases teamwork and management of teams.

Examples of original publications are:

  • Erb-Zohar K, Sourgens H, Breithaupt-Groegler K, Klipping C.
    Unintended drug exposure during pregnancy in clinical trials - a survey in early drug development.
    Int J Clin Pharmacol Ther. 2021;59(1):26-30.
  • Erb-Zohar K, Sourgens H, Breithaupt-Groegler K.
    Use of integrated clinical trial protocols - a survey in early medicines development.
    Int J Clin Pharmacol Ther. 2018;56(5):205-211.
  • Erb-Zohar K, Kropeit D, Scheuenpflug J, Stobernack H-P, Hulskotte EGJ, van Schanke A, Zimmermann H, Rübsamen-Schaeff H.
    Intravenous Hydroxypropyl β-Cyclodextrin Formulation of Letermovir: A Phase 1, Randomized, Single-Ascending, and Multiple-Dose Trial.
    Clin Transl Sci. 2017 Nov;10(6):487-495.
  • Kropeit D, Scheuenpflug J, Erb-Zohar K, Halabi A, Stobernack HP, Hulskotte EG, van Schanke A, Zimmermann H, Rübsamen-Schaeff H.
    Pharmacokinetics and safety of letermovir, a novel anti-human cytomegalovirus drug, in patients with renal impairment.
    Br J Clin Pharmacol. 2017;83:1944-1953.
  • Breithaupt-Groegler K, Coch C, Coenen M, Donath F, Erb-Zohar K, Francke K, Goehler K, Iovino M, Kammerer KP, Mikus G, Rengelshausen J, Sourgens H, Schinzel R, Sudhop T, Wensing G.
    Who is a 'healthy subject'?-consensus results on pivotal eligibility criteria for clinical trials.
    Eur J Clin Pharmacol. 2017 Apr;73(4):409-416.
  • Skarke C, Jarrar M, Erb K, Schmidt H, Geisslinger G, Lötsch J.
    Respiratory and miotic effects of morphine in healthy volunteers when P-glycoprotein is blocked by quinidine.
    Clin Pharmacol Ther. 2003;74:303-311.
  • Hermann R, Ferron G, Erb K, Knebel N, Ruus P, Paul J, Richards L, Cnota HP, Troy S.
    Effects of age and sex on the disposition of retigabine.
    Clin Pharmacol Ther. 2003;73:61-70.
  • Erb K, Klipping C, Duijkers I, Pechstein B, Schueler A, Hermann R.
    Pharmacodynamic effects and plasma pharmacokinetics of single doses of cetrorelix acetate in healthy premenopausal women.
    Fertility and Sterility. 2001;75:316-323.
  • Nagaraja NV, Pechstein B, Erb K, Klipping C, Hermann R, Niebch G, Derendorf H.
    PK/PD modeling of cetrorelix, an LHRH antagonist, after subcutaneous administration in healthy premenopausal women.
    Clin Pharmacol Ther. 2000;68:617-625.
  • Erb K, Pechstein B, Schueler A, Engel J, Hermann R.
    Pituitary and gonadal endocrine effects and pharmacokinetics of the novel LHRH antagonist teverelix in healthy men – a first-dose-in-humans study.
    Clin Pharmacol Ther. 2000,67:660-669.
  • Belz GG, Breithaupt K, Erb K, Kleinbloesem CH, Wolf GK.
    Influence of the ACE inhibitor cilazapril, the ß-blocker propranolol and their combination on haemodynamics in hypertension.
    J Hypertension. 1989;7:817-824. (based on K. Erb-Zohar’s thesis)

Please contact us for her CV and a full list of publications.

Network

Drug Development & Clinical Expertises

Dr. med. Robert Hermann

www.cr-appliance.de

Dr. med. Kerstin Breithaupt-Grögler

-kbr- clinical pharmacology services
breithaupt-groegler[@]t-online.de

Prof. Dr. med. Hildegard Sourgens

www.sourgens.de

Toxicoloy/Pharmacology

Dr. med. vet. Stephanie Plassmann

PreClinical Safety (PCS) Consultants Ltd www.pcsconsultants.com

Safety/Pharmacovigilance

Dr. Martin Coenen

Universitätsklinikum Bonn
martin.coenen[@]ukbonn.de

Trial Management

Dipl.-Oecotroph. Silke Gerrath

www.gerrath-clinical-research.de

Recruiting

Dipl.-BW Andreas Göring, BA

emfelia GmbH www.emfelia.de

Business Development

Dipl.-Ing. Claus Hemker

www.claus-hemker.com