Project Management

Clinical research is the fundamental basis of medical progress. It is a long path from the initial idea to the commercialization of a drug or a medical product. Following the completion of the pre-clinic stage, Clinlogix will accompany you with professional support from phase I onwards – from research to market launch, or to indication expansion if deemed necessary. No less challenging is the development of a medical product and obtaining Marketing Clearance, CE mark for Europe, respectively. With our service portfolio, we can offer you almost any assistance during the life cycle of your medical product.


  • Phase I – first human dose (first-in-man study, PK/PD studies, bioavailability)
  • Phase II – proof-of-concept studies
  • Phase III – safety and efficacy studies
  • 510(k) submissions and PMA applications, Investigational Device Exemptions (IDE)
  • DIMDI Submissions
  • Performance evaluations

Market authorization

  • Application for market authorization
  • Scientific conferences, publications, marketing and sales
  • Phase IV – marketing / post-authorization safety studies / indication expansion

Our support during Project preparatory, implementation, and completion Phase
From A to Z – After detailed consultation and planning, the Clinlogix team will support you in all of your individually tailored project needs. You decide which services you actually require, e.g.:

  • Preparation of all essential Documents: such as Protocol, Informed Consent Form, Patient information
  • Site Feasibility check, including selection and recruiting of study sites
  • CRF design (electronically and/or paper based)
  • IRB / Ethical Review Board proceedings: Support, preparation, conduct and follow-up of clinical trial submission to IRBs, local and national authorities; as well as the German Institute of Medical Documentation and Information in USA, Germany, and Colombia
  • Organization and conduct of investigator meetings or start-up visits
  • Project Controlling
  • CRA trainings (study-specific training of monitors)
  • Drug, material and laboratory logistics
  • Supervision of Vendors
  • Development of study Database
  • Selection and organization of the randomization procedure (in collaboration with our quality management)
  • GCP-compliant project documentation in the Trial Master File and the investigator site file(s)
  • Monitoring Supervision
  • Site Management
  • Database close
  • Analysis / Statistics
  • Reporting (to regulatory bodies)