Partnering with Pharmaceutical Leaders Active in Clinical Research

1. Partnering with Pharmaceutical Leaders Active in Clinical Research

2. DO IT RIGHT THE FIRST TIME! Company Overview • Berlin-based CRO • Founded in 2004 • Foundingmemberof MEDIS RESEARCH GROUP • Audited member of BVMA e.V. (in association withEUCROF) 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 www.allied-clinical.com 2

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 www.allied-clinical.com 3

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. • 2013 ACM and ICRC-Weyer (Germany) collaborateasthe MEDIS RESEARCH GROUP toprovidefull CRO service. www.allied-clinical.com 4

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

6. 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 www.allied-clinical.com 6

7. 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 www.allied-clinical.com 7

8. 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 www.allied-clinical.com 8

9. 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 www.allied-clinical.com 9

10. 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 www.allied-clinical.com 10

11. 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 www.allied-clinical.com 11

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 www.allied-clinical.com 12

13. 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.) www.allied-clinical.com 13

14. 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 www.allied-clinical.com 14

15. 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 www.allied-clinical.com 15

16. 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 www.allied-clinical.com 16

17. 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 www.allied-clinical.com 17

18. DO IT RIGHT THE FIRST TIME! Experience: Study Types www.allied-clinical.com 18

19. DO IT RIGHT THE FIRST TIME! Experience: Therapeutic Areas www.allied-clinical.com 19

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 www.allied-clinical.com 20

21. 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) www.allied-clinical.com 21

22. DO IT RIGHT THE FIRST TIME! Contact • Allied Clinical Management GmbH MEDIS RESEARCH GROUP • Berlin office: info@medis-research.com • Boyenstraße 41 www.medis-research.com 10115 Berlin Tel: +49 30 - 240 47 88 0 • +49 30 - 240 47 88 22Fax:+49 30 - 240 47 88 29 22 • info@allied-clinical.com • www.allied-clinical.com www.allied-clinical.com 22