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KOEHLER eClinical GmbH

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Freiburg, DE

About KOEHLER eClinical GmbH

KOEHLER eClinical is the successor company which was formed by the merger of Dr. Manfred Koehler GmbH Pharma Biometrics Consulting and its affiliated company clinIT AG, specialized in EDC solutions.

Having started as a company specialized in data management, biostatistics and EDC solutions we have broadened... Show more »

KOEHLER eClinical is the successor company which was formed by the merger of Dr. Manfred Koehler GmbH Pharma Biometrics Consulting and its affiliated company clinIT AG, specialized in EDC solutions.

Having started as a company specialized in data management, biostatistics and EDC solutions we have broadened our core portfolio with full-service clinical projects.

Our innovative concepts and a well-proven network of monitors and regional partner CROs allow us to conduct global projects without being a global CRO.

Being one of the pioneer companies who developed and applied an EDC application for collecting and managing clinical data, we utilize our user-friendly, intuitive and flexible tool to optimize the data collection and management process. Unlike EDC providers who offer solely a standard product, we offer our customers a possibility to develop unique customized features according to their requirements.

Selected Publications

  • UCHNER A, WEIDEMANN A, WILLENBROCK R, PHILIPP S, HEINICKE N, RAMBAUSEK M, MEHDORN U, FRANKENGERGER B, ET AL, mprovement of the cardiac marker N-terminal-pro brain natriuretic peptide through adjustment for renal function: a stratified multicenter trial. Clin Chem Lab Med.2010; 48(1):121-128
  • GEISTHÖVEL F, WACKER A, BRABANT G, BOTSCH F, MAECHTEL A, WETZKA B, OCHSNER A, Novel Systematics of Nomenclature and Classification of Female Functional Androgenization (Including Polycystic Ovary Syndrome and Non-Classic Congenital Adrenal Hyperplasia). J Reproduktionsmed Endokrinol. 2010;7(1): 6-26
  • MOENCH C, BECHSTEIN WO, HERMANUTZ V, HOEXTER G, KNAEBEL HP, Comparison of the collagen haemostat Sangustop® versus a carrier-bound fibrin sealant during liver resection; ESSCALIVER-Study. Trials. 2010 Nov 19; 11:109
  • BARLESI F, PAZZOLA A, GORBOUNOVA V, GROSSI F, KÖHLER M, MEZGER J, PETERS F, TRIGO JM, VIKSTROM A, GROEN HJM, Maintenance Bevacizumab with or without Pemetrexed (PEM) following first-line Bevacizumab-Cisplatin (CIS)-PEM in patients (PTS) with advanced non-squamous non-small cell lung cancer (NSCLC). - Preliminary safety data from AVAPERL1 (MO22089), Poster presentation, ESMO 2010, Milan
  • Buzdar AU, Xu B, Digumarti R, Goedhals L, Hu X, Semiglazov V, Cheporov S, Gotovkin E, Hoersch S, Rittweger K, Miles DW, O'Shaughnessy J, Tjulandin S, Randomized phase II non-inferiority study (NO16853) of two different doses of capecitabine in combination with docetaxel for locally advanced/metastatic breast cancer. Ann Oncol. 2012 Mar; 23(3):589-97
  • DANSIN E, CINIERI S, GARRIDO P, GRIESINGER F, ISLA D, KOEHLER M, KOHLHAEUFL M, MO19390(SAiL): bleeding events in a phase IV study of first- line bevacizumab with chemotherapy in patients with advanced non-squamous NSCLC. Lung Cancer. 2012 Jun;76(3):373-9
  • Schmoll HJ, Tabernero J, Maroun J, de Braud F, Price T, Van Cutsem E, Hill M, Hoersch S, Rittweger K, Haller DG, Capecitabine Plus Oxaliplatin Compared With Fluorouracil/Folinic Acid As Adjuvant Therapy for Stage III Colon Cancer: Final Results of the NO16968 Randomized Controlled Phase III Trial. J Clin Oncol. 2015 Nov 10;33(32):3733-40. doi: 10.1200/JCO.2015.60.9107
  • Krämer BK, Montagnino G, Krüger B, Margreiter R, Olbricht CJ, Marcen R., Sester U, Kunzendorf U, Dietl KH, Rigotti P, Ronco C., Hörsch S, Banas B, Mühlbacher F, Arias M, Efficacy and safety of tacrolimus compared with ciclosporin-A in renal transplantation: 7-year observational results. Transpl Int. 2016 Mar;29(3):307-14. doi: 10.1111/tri.12716.
  • Sunil S. Badve, Yesim Gökmen-Polar, Silke Hoersch, Jin Xu, Josef Ruschoff, Sanne de Haas, Sunil Verma; Indiana University, Indianapolis, IN; Indiana University School of Medicine, Indianapolis, IN; Dr. Manfred Köhler GmbH/Roche, Freiburg, Germany; Genentech, Inc., South San Francisco, CA; Institut für Pathologie Nordhessen and Targos Molecular Pathology GmbH, Kassel, Germany; F. Hoffmann-La Roche Ltd., Basel, Switzerland; Cumming School of Medicine, University of Calgary, Calgary, AB, Role of tumor infiltrating lymphocytes (TILs) in HER2+ metastatic breast cancers (MBC) treated with trastuzumab emtansine (T-DM1) or lapatinib plus capecitabine (L+C) (EMILIA Trial). Poster at ASCO 2016
  • Shang-Chiung Chen, Angelica Quartino, Daniel Polhamus, Matthew Riggs, Jonathan French, Xin Wang, Shweta Vadhavkar, Melanie Smitt, Silke Hoersch, Alexander Strasak, Nataliya Chernyukhin, Jin Yan Jin, Sandhya Girish, Chunze Li, Population pharmacokinetics (PK) and exposure- response (E-R) analysis of trastuzumab emtansine (T- DM1) in patients with HER2+ metastatic breast cancer (MBC) who have received at least two prior regimens of HER2-directed therapy (TH3RESA). Poster at San Antonio Breast Cancer Symposium (SABCS) 2016
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Our Services (13)


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Biostatistical Analysis

Price on request
  • Contribution to study design
  • Power analysis and sample size calculation
  • Randomization
  • Statistical analysis plans
  • Periodic data monitoring and safety reviews by data safety monitoring board
  • Statistical modelling
  • Statistical analysis
  • Statistical reports
  • Statistical support for publications
  • SAS programming
  • CDISC
  • Contribution to study design
  • Power analysis and sample size calculation
  • Randomization
  • Statistical analysis plans
  • Periodic data monitoring and safety reviews by data safety monitoring board
  • Statistical modelling
  • Statistical analysis
  • Statistical reports
  • Statistical support for publications
  • SAS programming
  • CDISC
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Clinical Data Management

Price on request
  • (e)CRF design
  • Database setup and maintenance
  • CRF tracking and status reporting
  • Data entry
  • External data integration (e.g. central lab data, ECG data)
  • Data validation and query management
  • Medical review
  • Serious Adverse Events (SAE) reconciliation
  • Coding (e.g. MedDRA, WHO-Drug Dictionary)
  • Database transfer
  • SDTM mapping
  • (e)CRF design
  • Database setup and maintenance
  • CRF tracking and status reporting
  • Data entry
  • External data integration (e.g. central lab data, ECG data)
  • Data validation and query management
  • Medical review
  • Serious Adverse Events (SAE) reconciliation
  • Coding (e.g. MedDRA, WHO-Drug Dictionary)
  • Database transfer
  • SDTM mapping
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Project Management

Price on request

Together with our strategic partner AKP specialized in clinical project management and clinical operations we offer:

  • Medical consulting in planning and conduct phase
  • Input in development of study design
  • Feasibility check and site selection
  • Project management
  • Contract management
  • Regulatory submissions
    -... Show more »

Together with our strategic partner AKP specialized in clinical project management and clinical operations we offer:

  • Medical consulting in planning and conduct phase
  • Input in development of study design
  • Feasibility check and site selection
  • Project management
  • Contract management
  • Regulatory submissions
  • Monitoring and site management
  • Investigator meetings
  • Site and personnel trainings
  • Handling of investigator fees
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Medical Writing

Price on request
  • Clinical protocol/Informed consent/Investigator brochure/Clinical study report
  • Abstracts, manuscripts & journal articles
  • Manuscript submissions for scientific publications
  • Clinical protocol/Informed consent/Investigator brochure/Clinical study report
  • Abstracts, manuscripts & journal articles
  • Manuscript submissions for scientific publications
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Process Consulting

Price on request
Request a quote for more information about this service.

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Clinical Data Collection, Analysis and Management

Price on request
Request a quote for more information about this service.

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Marketing, Communication & Graphic Design Services

Price on request
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Computational Modeling

Price on request
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Editorial and Writing Services

Price on request
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Biostatistics & Bioinformatics

Price on request
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High Performance Computing

Price on request
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Data Services

Price on request
Request a quote for more information about this service.

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Clinical Research

Price on request
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