CCDRD AG
Booth number: 26 - 07
www.ccdrdag.com
About us
CCDRD – Clinical Studies from Concept to Market
CCDRD is an established Contract Research Organization (CRO) with 35 years of experience in conducting clinical trials. The company is headquartered near Berlin, Germany.
Geographic Presence
CCDRD operates comprehensive clinical infrastructure across the following countries:
Germany, The Netherlands
Bulgaria, Poland, Hungary, Romania, Moldova
Serbia, Croatia, Türkiye
Phase I Clinical Trial Units
The company operates four specialized units for healthy volunteer studies:
In Bulgaria:
Bulgaria I (18 beds) – inspected by ANSM (FR), BDA (BG)
Bulgaria II (12 beds) – inspected by FDA (USA), BfArM (DE), BDA (BG)
Bulgaria III (12 beds) – inspected by BDA (BG
In Türkiye:
Türkiye I (48 beds) – inspected by MoH (TR), BfArM (DE), MCC (RSA), AGES (AU), AEMPS (ES)
All units are equipped with PK sampling facilities, spirometry equipment, inhaler training, cardiovascular and vital signs monitoring, and ICU access in selected units..
Capability
CCDRD provides full-service for clinical Phase I-IV studies:
Regulatory Services and Clinical Strategy | Study Management | Clinical Conduct | Data Management and Statistics | Additional Services |
Expertise and Portfolio
Experience:
Approximately 1,200 Phase I trials
Approximately 150 clinical endpoint studies
Specialized Areas:
Orally Inhaled Products: Over 80 bioequivalence studies completed for EU and FDA (DPI, MDI devices)
Depot Injectables and Implants: Single and multidose trials
Transdermal Products: Bioequivalence and adhesion studies
Dermatologicals: Therapeutic equivalence trials
Ophthalmologicals: PK/PD studies in patients and healthy volunteers
Medical Indications
CCDRD conducts feasibility assessments in every indication, with particular experience in:
Oncology | CNS | Dermatology | Renal Disease | Allergology/ENT I Ophthalmology | Infectious Diseases | Gastroenterology | Metabolic Diseases | Respiratory Diseases | Cardiology | Pain Management | Rheumatology | Women's Health
Regulatory Environment
EEA (CTIS): DE, PL, BG, HU, HR, NL
Outside EEA: MD, RS, TR
Contact us – Be First.
Address
Lindenallee 70
15366 Hoppegarten
Germany
E-mail: contact@ccdrdag.com
Phone: +49 3342 2379-0
Internet: www.ccdrdag.com
Contact person:
Dr. Petra Kowalski
Director Business Development
E-mail: pkowalski@ccdrdag.com
Products & Services
Capability Portfolio
CCDRD provides full-service for clinical Phase I-IV studies:
Regulatory Services and Clinical Strategy:
Clinical strategy and study design consultation
Scientific Advice with EMA, FDA, and national European authorities
Medical writing and documentation
Preparation and submission of regulatory packages with follow-up
Translations and study insurance services
Study Management:
Feasibility assessments and site identification/qualification
Patient and volunteer recruitment
Project management with frequent sponsor status reporting
Organization of investigator meetings
Monitoring by qualified CRAs in all countries
Clinical Conduct:
Site identification, qualification
Prequalified, inspected clinical units for phase I studies
Investigator and Institutional Contracting
Medical monitoring
ITF and supply provision
Study oversight
Additional Services:
IMP supply and labeling services
Pharmacovigilance
Data management, statistics, eCRF/EDC
Study logistics and sample transport
Bioanalytical and Central Laboratory services