Acromion Gmbh

acromion GmbH is an independent, privately owned Contract Research Organization (CRO) based in Europe with extensive experience in medical and bioscientific research. The organization supports pharmaceutical, biologics, and medical device sponsors in clinical development for both human and veterinary markets.

Core Services

• Clinical Operations & Monitoring: Study organization, conduct, and clinical monitoring across Phase I–IV and non-interventional studies (NIS). Clinical research associates manage investigative sites with professional dedication.
• Data Management: Full clinical data management support with study-specific database development. Delivers data in CDISC SDTM and CDISC ADAM formats when requested, with flexible EDC solutions and ePRO/eDiary capabilities.
• Biostatistics: Comprehensive statistical consulting for all biometrical aspects of clinical studies, epidemiologic studies, and registries. Senior biostatisticians bring three decades of clinical research experience across numerous therapeutic areas.
• Medical Writing: Comprehensible transfer of study concepts, protocols, reports, and documentation according to international standards and regulatory guidelines.
• Quality Assurance: Continuous advancement of quality assurance activities ensuring all ethical and regulatory requirements are met.
• Safety Surveillance & Pharmacovigilance: Medically qualified professionals provide support to sponsor pharmacovigilance departments in close collaboration with project management and specialized partner networks.
• Regulatory Affairs: Expertise in regulatory database management and submission processes, including experience with EU Clinical Trials Regulation (CTR 536/2014) and CTIS portal applications.
• Project Management: Scientific specialists and clinical research experts serve as dedicated points of contact throughout project duration, tailored to individual sponsor needs.

Differentiation

acromion emphasizes competency, transparency, and accountability. The organization proactively identifies and addresses emerging issues, adopts sponsor SOPs, and collaborates effectively with established partner networks. Regular progress reporting and prompt issue escalation are core commitments.