Opera performs Clinical Trials from Phase I to IV in a wide range of countries: East and West Europe, South America and Asia (Middle and Far East), obviously depending on Sponsor’s necessities. Clinical trials related services include all necessary activities starting from Trial Design, Protocol writing, sites selection, ethic-administrative Submissions, Monitoring and Data Management up to Statistical Analysis and Medical Writing.

Clinical Trial Preparation

Opera provides support for study design and protocol development in the early preparation stages of a clinical trial program, as well as for CRF design and computerized databases in order to ensure the optimization of the data collection and organization process.

Informed Consent Forms, Patient Information Leaflet and operation manuals can be customized following the specific Sites and projects needs.

Our clinical team can easily manage the preparation of the Trial Master File (TMF) and Trial Centers File (TCF) following our Standard Operating Procedures.

Also, we can contribute to the development of the randomization procedures in accordance with the requirements of the study protocol.

These activities include the following:

  • Study planning process for regulatory authorities
  • Clinical trial risk assessment
  • Clinical Study Rationale
  • Clinical Study Protocol and Synopsis
  • Case Report Form (CRF) and Patient Diary
  • CRF and Patient Diary Manual
  • Investigational Medicinal Product Dossier (IMPD)
  • Investigator Brochure (IB)
  • Laboratory Manual
  • Patient Information Leaflet (PIL) and Informed Consent (IC)
  • Electronic CRF (e-CRF)
  • Trial Master File (TMF)
  • Trial Center File (TCF)

Selection of Investigators and Sites

Adequate Site selection, management and assistance are vital to a study’s successful outcome. Opera provides to the selection of experienced investigators and gives recommendations based upon past experience with reputable institutions.
These activities include the following:

  • Investigator / Site screening
  • Investigator / Site selection (Final list & Back-up Sites)
  • Pre-Study Site visit
  • Investigator contracts management and grants negotiation

Protocol Submission to Regulatory Authorities

Opera provides full services to ensure the clinical protocol approval by Ethical Committees and Regulatory Authorities. Our start up and legal offices manage specific regulatory submissions in compliance with national and international requirements to assure the higher probability of success.

These activities include the following:

  • To complete the Regulatory Dossier for the Site Coordinator and Satellite Sites.
  • Protocol and amendments submissions to the Ethics Committee and Regulatory Authorities.
  • Assistance and guidance during the Ethics Committee approval (clarifications and answers to Ethical Committee questions).
  • Site Contract Template and final version negotiation with the Site Legal Office.

Clinical Monitoring

Opera assignes to each project a collaborative team with considerable experience, with the aim to provide efficient site and patient enrollment, training, and site support. During these years we have given special attention to the process of staff selection to obtain skilled and well-trained clinical research associates (CRAs). The highest quality review of data and effective interaction with study sites are the top priorities of our Clinical Operation team during the-site monitoring visits.

In addition, Opera customizes for each project a monitoring plan using references such as the protocol complexity and timelines, the recruitment expectations, the experience of the involved Investigators, and the site facilities.

These activities include the following:

  • Monitoring Plan design
  • Initiation visit
  • Interim Monitoring visit
  • Closure visit
  • Data Clarification Forms (DCF)

Management

Our experienced Clinical Project Managers are responsive and proactive, and ensure that the right resources are used with established procedures to maximize efficiency throughout your study. The goal is to to make sure that your project is completed in optimal time, on budget, within the international quality standards and fully complying with the Good Clinical Practice principles.

These activities include the following:

  • Clinical Trial status report and communication with the Sponsor (written reports, phone and videoconference calls)
  • Contacts (information updates) with Investigators/Ethics Committees
  • Adverse Events and SUSAR Management, reporting and follow-up

Data Management and Statistics

Data management is is a critical phase in clinical research, which leads to generation of high-quality, reliable, and ready to be statistically analyzed  data. In Opera the members of Data management unit are involved from the beginning to the completion of a clinical trial. All the following procedures are assessed for quality at regular intervals during a trial: CRF and database design, data-entry, data validation, discrepancy management, medical coding, data extraction, and database locking.

These activities include the following:

  • Randomization management
  • Data Management Plan design
  • Database set up and Validation
  • Data entry
  • Coding
  • Handling Data Clarification Forms (DCFs)
  • Clean filing
  • Transfer Database to Sponsor
  • Statistical Analysis Plan design
  • Final Statistical Analysis

Medical Writing and Reporting

Opera pays special attention to this chapter, by carefully supervising and verifying the compliance of the reported data with the actual facts. Our services guarantee the Client a clear and complete evidence of all information, in full compliance with national and international Regulatory.

These activities include the following:

  • Interim and Final Analysis Report (ICH-GCP Compliant )
  • Presentation tools (Poster/slides for Congress or Meeting)
  • Articles for scientific publication