MEDICAL WRITING

  • Writing and revision of study related documentation such as protocol, Investigator’s Brochure (IB), Investigational Medicinal Product Dossier (IMPD), information sheets, informed consent forms, study-specific procedures, Clinical Study Report (CSR) and other.
  • Scientific publications

REGULATORY AFFAIRS

  • Preparation of documentation for submission to competent authorities and ethics committees for authorisation to perform the clinical trials
  • Management of the regulatory process of a clinical trial from initial submission to the end of the study
  • Translation of dossiers, clinical protocols, information sheets and consent forms, and other documentation to be included in Clinical Trial Application

PHARMACOVIGILANCE

  • Supporting Sponsor in registration to EudraVigilance
  • Definition of security section of clinical study protocol
  • Safety Management Plan preparation
  • Collection, processing and reporting of Serious Adverse Events/Serious Adverse Reactions
  • Medical review of safety data
  • Collection, processing and reporting of SUSAR (suspect unexpected serious adverse reactions) to Competent Authorities (through EudraVigilance, if applicable) and ethic committees, as well as distribution of line listing to investigators
  • Preparation and submission of Development Safety Update Report to competent authorities and ethic committees
  • MedDRA coding

TRIAL OPERATIONS

  • Contract negotiation between Sponsor and Sites
  • Site management, including queries resolutions, deviation management, corrective and preventive actions
  • Preparation e management of Trial Master File
  • Investigator Site File preparation and support for updates during the site monitoring visit

MONITORING

  • Feasibility check of the study at the centres and their selection
  • Qualification of centres
  • Monitoring: study start visit, monitoring visit, study close visit, even remotely where applicable
  • Centralized monitoring (with support of data management function)

DATA MANAGEMENT

  • Design and development of Case Report Form (CRF) (paper and electronic)
  • Data Management Plan preparation
  • Database design in accordance with CDISC/CDASH standards
  • e-CRF hosting and backup
  • Management of accesses to the e-CRF, training and technical user’s support
  • Data management, data entry and database lock
  • Medical coding (adverse events, concomitant medications, concomitant disease)
  • Data cleaning
  • Reconciliation of serious adverse events