MEDICAL WRITING
Clinical Protocol development (UNI EN ISO 14155: 2020 and ICH-GCP).
Clinical Study Report development (ICH-GCP).
Informed Consent Form development.
Documents for Investigator's Meetings (abstracts, posters, presentations).
Literature Research.
SITE SELECTION AND FEASIBILITY
Adherence to the project and to the needs of the Sponsor.
Coverage of different therapeutic areas.
Adequacy of recruitment potential.
Staff adequacy, extensive experience.
Data Quality level adequacy.
REGULATORY AFFAIRS
Development of regulatory documents for ECs and CAs.
Study submission to ECs and CAs.
Negotiation and finalization of financial agreements.
Obtaining ECs opinions and CAs authorizations.
Periodic notification to ECs and CAs.
PROJECT MANAGEMENT
Flexible budget models.
Identifying winning strategies and creating appropriate timelines.
Identification and timely resolution of problems.
Efficiency in communication processes between all parties.
Constant reporting.
MONITORING
Feasibility, start-up, routine, unscheduled and close-out visits.
Expedited planning and preparation of visits.
Development of Visit Reports to Sponsor and Follow-up letters to Investigators.
Certified and experienced CRA.
Development of Clinical Monitoring Plan based on risk assessment.
DATA MANAGEMENT
Data Management Plan development.
Case Report Form (CRF) development and eCRF implementation (CFR 21 part 11 compliant).
Clinical Database development and maintenance.
Validation of data through edit checks and ad hoc electronic tools.
Data encoding (Adverse Events and Concomitant Treatments).
Import of clinical data and data transfer.
BIOSTATISTICS
Input to Clinical Study Protocol.
Development of the Statistical Analysis Plan (SAP).
Development of the randomization list
Tables, Listing and Figures (TLF).
Interim and final statistical analysis.
Management of Data Monitoring Boards (DMBs).
Statistical advisory.
PHARMACOVIGILANCE
Receipt and review of SAE reports (initial and follow-up).
Recovery of missing information and requests for clarification.
Transmission of SAE reports (initial and follow-up) to the PV office of the Sponsor.
Recording of SAEs in the safety database and encoding of terms.
Development and submission of periodic safety reports.
SAEs reconciliation.
