ALLIED CLINICAL MANAGEMENT GMBH Partnering with Partnering with - - PowerPoint PPT Presentation

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ALLIED CLINICAL MANAGEMENT GMBH Partnering with Partnering with - - PowerPoint PPT Presentation

ALLIED CLINICAL MANAGEMENT GMBH Partnering with Partnering with Pharmaceutical Leaders Active in Clinical Research Facts and Figures Founded in 2004 Client Base Includes Large Pharma and Regional Biotechs Audited Member of BVMA


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ALLIED CLINICAL MANAGEMENT GMBH

Partnering with Partnering with Pharmaceutical Leaders Active in Clinical Research

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  • Founded in 2004
  • Client Base Includes Large Pharma and Regional Biotechs
  • Audited Member of BVMA (German Federal Association of CROs) since 2009

Facts and Figures

  • Clinical Trial Monitoring and Management of Phase I to Phase IV Trials
  • Extensive Experience Monitoring Oncology, CNS and Cardiovascular disease

Trials

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  • Agile, customer-focused management
  • ICH-GCP trained clinical monitor team
  • Accessible CRAs dedicated to delivering key information quickly

Characteristics

  • Highly trained and motivated staff
  • Quality at an affordable price
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  • Site Selection Visits
  • Site Initiation Visits
  • Investigator and Clinical Staff Training

Clinical Trial Monitoring

  • Interim Monitoring Visits
  • Query Resolution
  • Drug Accountability
  • Site Close Out Visits
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  • Site Feasibility
  • EC and RA Submissions
  • Creation of Study Operation Guides / Monitoring Guidelines

Study Management

  • Consultation on Creation of CRFs, Patient Diary and Study Logs
  • Study Budget Set-Up and Cost Tracking of Investigator Payments
  • Study Newsletter
  • Clinical Document Translation
  • Proof-Reading
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SLIDE 6

Proof-reading and translating services of key clinical texts performed by native English and German speakers with experience both in clinical translation/proof-reading

Translations and Proof-Reading

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Areas of Expertise

  • Central Nervous System
  • Oncology
  • HIV / Infectiology
  • Female Contraception
  • Female Contraception
  • Dermatology
  • Metabolic Disorders
  • Cardiovascular Disease
  • Ophthalmology
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SLIDE 8

Flexibility

agile, adaptive, responsive tailored, modular services

Quality

experienced trained, delivering critical

Strengths

Quality

trained, ethical critical information

Efficiency

prepared, swift, affordable faster results to clients

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Sponsors:

Bayer Health Care Elbion AG Bayer Schering Pharma AG GALENpharma BioMS Medical Corp Novartis Biotie Therapies Weleda AG

Partners:

CSG Clinische Studien Gesellschaft Scope Life Sciences

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Michael Roehl Managing Director Allied Clinical Management GmbH Boyenstrasse 41

Contact:

Boyenstrasse 41 10115 Berlin, Germany Phone: +49 (0)30 240 4788 10 Fax: +49 (0)30 240 4788 2910 Email: roehl@allied-clinical.com www.allied-clinical.com

Allied Clinical Management GmbH ● Hamburger Strasse 14 / 16341 Panketal Managing Directors: Michael Roehl / Jörg Korb ● Registered in: Frankfurt / Oder, Germany Registration Number: HRB 11077 FF ● Legal Authority: Berlin, Germany VAT registration number: DE 249 407 981 ● German Federal Tax Number: 065/105/00960