Partnering with Pharmaceutical Leaders Active in Clinical Research

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 www.allied-clinical.com 2

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

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) collaborate as the MEDIS RESEARCH GROUP to provide full CRO service. www.allied-clinical.com 4

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 www.allied-clinical.com 5

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 www.allied-clinical.com 6

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 www.allied-clinical.com 7

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 www.allied-clinical.com 8

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 www.allied-clinical.com 9

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 www.allied-clinical.com 10

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 www.allied-clinical.com 11

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

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.) www.allied-clinical.com 13

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 www.allied-clinical.com 14

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 www.allied-clinical.com 15

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 www.allied-clinical.com 16

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 www.allied-clinical.com 17

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

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

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

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) www.allied-clinical.com 21

Contact Allied Clinical Management GmbH MEDIS RESEARCH GROUP 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 22 Fax:+49 30 - 240 47 88 29 22 info@allied-clinical.com www.allied-clinical.com www.allied-clinical.com 22