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.

Clinic

  • 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)