Our medical management handles a range of activities regarding the trial’s operative process.
The main activities are listed below:
1) Site Selection
Analysis of previous site experiences;
Notification from other investigators;
Analysis of bibliographic material;
Investigator's qualification, education and training (curriculum vitae) and capability of taking the responsabilities for a correct trial conduction;
Potential Enrolment Estimate;
Catchment Area Evaluation;
Temporal Availability for the clinical trial;
Adequate management of the documents;
Adequate facilities (centrifuge, laboratory, instruments...).
D.M. 15/07/97, G.U. n.°191 del 18/07/97 - ICH Acknowledgment
2) Site Opening
3) Organization and Participation in the Investigator's Meeting
Planning and Payments for the Investigators' transfers;
Organization of catering
Drafting of the Operative Handbook on trials for the Investigators;
Protocol and Case Report Form (CRF) Submission;
Practical exercises on Crf completion, analysis and review of prospective problems with the protocol
Adverse Events notification: definition, classification and submission to the Health Authorities
Final discussion.
4) Clinical Monitoring and Recruitment
Clinical Monitoring is one of the most important steps in clinical trials;
we guarantee :
data quality,
safety review,
compliance check,
drug accountability,
protocol adherence,based on inclusion and exclusion criteria, including any screening failures.
Check on the correct compilation of Informed Consent Forms including any screening failures
Verification of Medical Notes and coherence between data reported on the CRFs and source
Check on the proper storage and maintaining of the documentation and supplies on site
Serious Adverse events, management according to the Sponsor Standard Operative Procedures(SOP)
CRFs collection
Drug Accountability
Drawing up of Monitoring Visit Reports Supplies collection and return to the sponsor at the end of the trial.
Drawing up of Study Close-Out Reports.
5) CRF Collection and Data Cleaning
6) Data and query Processing
7) Close-out and LTA
8) Final Report
9)Site Payment
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