OUR SERVICES

MCR has a consolidated experience and expertise to plan, set-up, coordinate and analyse research trials involving pre and post CE mark medical devices as well as phase I-IV clinical trials with medicinal products, observational trials and registries.
MCR is proud to support no-profit studies.

TRIAL DESIGN & SET-UP

  • Protocol Development
  • Protocol Review
  • Case Report Form design from protocol
  • Feasibility and Centers Selection
  • Organization of Investigators’ Meetings
  • Organization of study files for Investigators

Thanks to a network of experts, MCR has extensive experience in protocol development and protocol review. Manuals and research guidelines can be developed in collaboration with the Sponsor to ensure quality and data consistency.
MCR can either design paper CRF from the protocol or support the client to finalize a draft CRF. MCR has developed a proprietary web-based electronic Case Report Form (eCRF). Printing of traditional paper CRF, can also be taken in charge.
Although based in Italy, MCR can organise European multicentre trials, thanks to a network of CRA free-lance and collaborations with other CROs.


CENTRAL COORDINATION

  • Project Management:

    1. Coordination and supervision of CRAs activities.
    2. Monthly Reports and Newsletters to Investigators
    3. Ongoing updates to Sponsor
    4. Ongoing maintenance of the Trial Master File


  • Management of Study Committees:

    1. Data Safety and Monitoring Board
    2. Event Adjudication Committee

REGULATORY ASSISTANCE

  • Regulatory submission to Competent Authorithies and Ethics Committees.
  • Periodic reporting
  • Safety Reporting

MCR can manage regulatory submissions in Italy and provide support for regulatory procedures in Europe.
MCR can negotiate financial contracts on Sponsor's behalf.
MCR has good experience in notification of clinical investigations with medical devices to the Italian Ministry of Health and deep knowledge of the upcoming new European Regulation.
MCR can support the sponsor for reporting SUSARS to Health Authority and Ethis Committee as well as for distributing line listings to the investigators.


SITE MANAGEMENT

  • Feasibility
  • Site selection visits
  • Site initiation visits
  • Site Monitoring
  • Close Out visits
  • Audits

In-house and home-based qualified monitors ensure adherence to the protocol and GCP compliance.
MCR offers the possibility to monitor trials in Italy and in other European countries.
A set of internal SOPs for monitoring activities as well as monitoring forms are in place.
On site and off-site (remote and centralised) monitoring activities can be managed. Through the eCRF ongoing reports can be produced, which are a very useful tool for Sponsors for trial monitoring and study quality checks.

MCR has developed an internal Quality Control System to ensure adherence either to internal or to Sponsor SOPs from all involved staff. An external Quality Assurance system is ensured by a well experienced QA professional.


DATA MANAGEMENT AND STATISTICS

  • Design Database
  • Perform Single and double Data Entry
  • Data management plan and reports
  • Data Monitoring and Auditing
  • Queries Generation
  • Coding of Medical terms and medications with dictionaries
  • SAE reconciliation
  • Data cleaning
  • Database Lock
  • Derived Data Set specifications
  • Production of tables, figures and listings
  • Generation of the randomization list
  • Sample size calculation
  • Interim and Final Statistical Analysis
  • Statistical Report
  • Final Clinical and Statistical Report

If paper CRF is required, a qualified staff of experienced data managers can develop databases for data entry according of protocol specificities and Sponsor's requirements.
MCR has developed a proprietary web-based electronic Case Report Form (eCRF) (see IDAS section).

Data Managers work under the supervision of a senior Service Responsible and in collaboration with the Project Leader to assure timely management of data. Prompt assistance to Investigators is ensured in case of technical questions.

The Statistical personnel in MCR have extensive experience in data analysis from clinical trials and can provide interim analysis, final analysis and stopping rules. The statistical staff is also involved in trial design, including protocol design, CRF development and data management.

MCR can provide final statistical and clinical study report according to ICH guidelines. Full or abbreviated Clinical and Statistical reports can be produced.


QCA (Quantitative Coronary Angiography Analysis)

MCR has a central core laboratory for analysis of coronary angiograms.

MCR core laboratory personnel have also gained extensive experience in qualitative angiographic analysis such as morphological lesion parameters, anatomy, TIMI frame count, Myocardial Blush, and Thrombus Score.

MCR routinely gives regular feedback to the Sponsor on images quality and adherence to protocol requirements to ensure high quality material for data analysis.

MCR can offer training courses on QCA analysis for physicians and technicians.


PHARMACOVIGILANCE

  • SUSAR Submission through the Eudravigilance database
  • Draw up and submission to the Health Authorities of Development Safety Update Reports (DSURs)
  • Medical Review