Pharma D&S

 

APPROACH to the FUTURE based on EXPERIENCE, INNOVATION and FLEXIBILITY

 

Clinical Trial

Clinical trials are medical investigations aimed at collecting data relating to safety and efficacy of medicines, medical devices, dietary supplements and cosmetics. These studies may be carried out only after satisfactory information regarding product characteristics and preclinical safety has been gathered.

Pharma D&S proposes itself as a "full service" business partner in the conduction of the following clinical trials:

• Phase II-IV Interventional Studies

• Non-Profit Studies

• Non-Interventional Studies (Observational and Register studies)

• Studies on Medical Devices, Cosmetics and Dietary Supplements.

 

The following services are offered:

 

PROJECT AND DATA MANAGEMENT

• Feasibility studies and selection of Participating Centres (phase II-IV)

• Preparation of the study protocol according to the Client company’s Standard Operating Procedures.

• Formulation and realization of CRFs, in both paper and electronic format

• Writing of the Informed Consent form and patient information sheet

• Management of the authorizations from the competent authorities

• Preparation of documents and “start-up” activities

• Submission of the study protocol to Ethics Committees: management of all activities related to the authorization of the Ethics Committees and contract closeout with the Institution itself

• Investigators Meetings

• Data Management with e-CRF through AS® PheedIt Solution for Life Science

• Management of clinical trial-related pharmacovigilance

• Collection of CRFs and DataCleaning

• Data Processing and Queries

• Statistical analysis with SAS/STAT ® software and with other statistical softwares

• Final Report

• Payment of compensations due to experimental centres

 

MONITORING

•Enrolment of qualified Monitors by means of a consolidated professionals network for the whole national coverage

• Monitors meetings

• Identification, evaluation and initial start-up visit of the centres participating in the study

• Check of the correct filling in of the informed consent form in 100% of patients, including possible screenings

• Verification of protocol compliance in terms of inclusion and exclusion criteria in 100% of patients

• Check of the correct storage and filing of all materials and documents at the Centres.

• Check of medical records and of compliance of all data reported in the CRFs, as well as of all raw data, in 100% of patients, including possible screening failures.

• Monitoring visits during the study, planned in accordance with the clinical trial’s and the involved experimental centres’ requirements

• Assessment of each single study monitor’s activity

• Close-out visit

• Writing of close-out reports

• Management of collection and return to the Sponsor of any residual materials at the end of the trial.

 

AUDITING

• GCP Audit at Clinical Centres

• GCP/GLP Audits at medical laboratories

 

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