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Partnering with Pharmaceutical Leaders Active in Clinical Research

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Presentation on theme: "Partnering with Pharmaceutical Leaders Active in Clinical Research"— Presentation transcript:

1 Partnering with Pharmaceutical Leaders Active in Clinical Research

2 Company Overview Berlin-based CRO Founded in 2004
DO IT RIGHT THE FIRST TIME! Company Overview Berlin-based CRO Founded in 2004 Founding member of MEDIS RESEARCH GROUP Audited member of BVMA e.V. (in association with EUCROF) since 2009 Specialist for study management and monitoring Client base: international and regional biotechs, large pharma Full-service in setting up and conducting clinical trials with our collaboration partners

3 DO IT RIGHT THE FIRST TIME!
Academic Sourcing Close relationship with academic institutions training clinical research professionals (Beuth Hochschule, Parexel Academy, Mibeg Institute) Placements for practical training and thesis work Early recruitment of top-of-their-class future professionals Capacity for sudden increase of employees High staff retention due to strong relationsships with employees

4 DO IT RIGHT THE FIRST TIME!
Company History 2004 founding Michael Roehl founds Allied Clinical Management. 2006 restructuring Jörg Korb (formerly Charité) joins Allied Clinical Management. Company restructures itself as a GmbH. 2008 first full study first full service study in indication ophthalmology performed. 2009 BVMA ACM joins BVMA. 2010 first med device first full service medical device study in indication cardio-vascular disease performed. ACM and ICRC-Weyer (Germany) collaborate as the MEDIS RESEARCH GROUP to provide full CRO service.

5 Proofreading and Translation
DO IT RIGHT THE FIRST TIME! Company Organisation General Management Office Management IT Support Quality Management Monitoring Study Documen-tation Regulatory Devices Ethic Submissions Pharmaco-vigilance Data Management Medical Writing Statistical Analysis Proofreading and Translation Study Management In-House External

6 Quality SOPs for all processes Document management
DO IT RIGHT THE FIRST TIME! Quality SOPs for all processes Document management Regular, documented GCP-Training for all employees Regular system audits by an independent auditor every 18 months Experience with CAPA-Processes and risk-based monitoring ACM is an audited member of the German Federal Association of Medical CROs (in association with the European CRO Federation) since 2009

7 Quality Management: Computer Security
DO IT RIGHT THE FIRST TIME! Quality Management: Computer Security Access-restricted and fire-protected facility Back-up IT-Systems Mirrored servers in separate locations Protected and access-controlled servers Firewall + virus protection Level-based access rights

8 Our Services Study Management Study Monitoring Study Documentation
DO IT RIGHT THE FIRST TIME! Our Services Study Management Study Monitoring Study Documentation Regulatory Services Proofreading and translation →services can be contracted à la carte Full Service as MEDIS RESEARCH GROUP

9 Study Management Oversight of study conduct and study monitoring
DO IT RIGHT THE FIRST TIME! Study Management Oversight of study conduct and study monitoring Budget management and tracking Primary contact for the sponsor Coordination of the study team Oversight of quality and timelines Risk assessment Vendor management Study set-up

10 Study Management TMF set-up and maintenance
DO IT RIGHT THE FIRST TIME! Study Management TMF set-up and maintenance Consulting on (e)CRF selection and design Site feasibility and site selection Organization / leading of investigator meetings Creation of study documents and study specific operation guides On-site sfety (AE / SAE / medical incidents) management Drug supply and destruction Clinical study report and review

11 Study Monitoring Full monitoring-service, on-site and remote
DO IT RIGHT THE FIRST TIME! Study Monitoring Full monitoring-service, on-site and remote Risk-based monitoring Site visits (selection, initiation, interim, close-out) Source data verification Check of study lists and documents ISF set-up and maintenance Training of site staff

12 DO IT RIGHT THE FIRST TIME!
Study Monitoring Monitoring compliance with ICH-GCP, study protocol and regulatory requirements AE / SAE management Conduct of interim analysis Query management Investigational product accounting Monitoring reports and follow-up letters

13 Study Documentation TMF set-up and maintenace
DO IT RIGHT THE FIRST TIME! Study Documentation TMF set-up and maintenace ISF set-up and maintenance Consultation on (e)CRF selection and design Design of study documents (logs, worksheets, manuals, guidelines, tracking lists etc.)

14 Regulatory Services Clinical trial applications Marketing applications
DO IT RIGHT THE FIRST TIME! Regulatory Services Clinical trial applications Marketing applications Medical device applications Collection of relevant documents Submission package for study initiation Submission of updated documents and changes Completion of checklists Correspondence with regulatory authorities and ethics committees Regulatory advice Quality review

15 Proofreading and Translation
DO IT RIGHT THE FIRST TIME! Proofreading and Translation Proofreading and translation of study protocols, patient diaries, patient information and informed consent and other key clinical texts Native English and German speakers

16 Full Service MEDIS RESEARCH GROUP offers its clients full CRO services
DO IT RIGHT THE FIRST TIME! Full Service MEDIS RESEARCH GROUP offers its clients full CRO services In addition to ACM services it offers: Biostatistics Data Management Medical Writing Pharmacovigilance Scientific Consulting

17 Experience with Remote Data Capture + Management Systems
DO IT RIGHT THE FIRST TIME! Experience with Remote Data Capture + Management Systems Medidata RAVE system RDC Oracle system Initiator eCRF system Science and technology on efficient information systems and study planning tools (IMPACT, Cognos clinical trial planning system etc.) and other clinical trial management systems Cost tracking tools

18 Experience: Study Types
DO IT RIGHT THE FIRST TIME! Experience: Study Types

19 Experience: Therapeutic Areas
DO IT RIGHT THE FIRST TIME! Experience: Therapeutic Areas

20 DO IT RIGHT THE FIRST TIME!
Countries ACM has monitored and performed oversight visits in the following countries: ● Austria ● Israel ● Czech Republic ● Latvia ● France ● Netherlands ● Germany ● Poland ● Great Britain ● Spain ● Hungary ● Switzerland ● Italy

21 Sponsors and Partners Sponsors ● Bayer Health Care ● GALENpharma
DO IT RIGHT THE FIRST TIME! Sponsors and Partners Sponsors ● Bayer Health Care ● GALENpharma ● Bayer Pharma AG ● Miltenyi Biotec GmbH ● BioMS Medical Corp ● Novartis ● Biotie Therapies ● Pluristem Ltd. ● Elbion AG ● Weleda AG Partners ● ICRC-Weyer (Germany)

22 Contact Allied Clinical Management GmbH MEDIS RESEARCH GROUP
DO IT RIGHT THE FIRST TIME! Contact Allied Clinical Management GmbH MEDIS RESEARCH GROUP Berlin office: Boyenstraße Berlin Tel: Fax:


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