The current administrative landscape for clinical trials is getting exceedingly and continuously more complex. Today's new research paradigm promotes multidisciplinary and inter-institutional research which would benefit from an integrated administrative academic infrastructure. Many interdependent functions are spread across the research enterprise, which has resulted in the establishment of an administrative structure of the Academic Clinical Research Office at the Medical University "Paraskev Stoynov"- Varna, which operates as separate, unbiased key structure that lacks policies or formal procedures for communication and interaction. We intend to assess, change, and improve clinical research administration to advance science, better serve patients nationwide as well as to increase access to information for the University as an Academic Educational center. By consolidation of those functions in the ACRO we help investigators manage studies and submissions to the institutional review boards (IRBs), as well as shorten times for contract negotiations and IRB approvals, improve coordination and communication with clinical sites.
We provide management of clinical trial operations, viewed as critical to the sustainability and growth of the research enterprise, addressing multiple regulatory requirements and administrative procedures before, during and after a clinical trial takes place. Our ACRO provides services as biopharmaceutical development, biologic assay development, preclinical research in our laboratories, clinical research (all phases), clinical trials management, and pharmacovigilance.
Optimization of clinical trials for better outcomes and best use of available funding, providing support to pharmaceutical, biotechnological and medical industrial companies.
Perform site selection, initiation, monitoring and close-out visits in accordance with contracted scope of work and good clinical practice.
- Provide monitoring visits and site management for a variety of protocols, sites and therapeutic areas.
- Administer protocol and related study training to assigned sites and establish regular lines of communication with sites to manage ongoing project expectations and issues.
- Evaluate the quality and integrity of study site practices related to the proper observation of the protocol and adherence to local applicable regulations. Escalate quality issues to Clinical Team Lead (CTL) and/or line manager.
- Manage the progress of assigned studies by tracking regulatory submissions and approvals, recruitment and enrollment, case report form (CRF) completion and submission, and data query generation and resolution.
- Create and maintain appropriate documentation regarding site management, monitoring visit findings and action plans by submitting regular visit reports and other required study.
- Design of a Clinical Trial
- Expert decision-taking and monitoring
- Financial project planning
- Regulatory consulting
- Project Management