MEDICAL WRITING

Clinical Protocol development (UNI EN ISO 14155: 2012 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
Developmen 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 eCF impementation (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
Recordng of SAEs in the safety database and encoding of terms
Development and submission of periodic safety reports
SAEs reconciliation

Clinical Research Technology S.r.l.
Sede operativa e legale Via San Leonardo – Traversa Migliaro, 84131 – Salerno
Telefono: +39 089301545 – Fax: +39 0897724155 – info@cr-technology.com

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Telefono: +39 08119572570 – Fax: +39 0897724155 – info@cr-technology.com

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