The melody in clinical trials

CLINICAL

OPERATIONS

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 the Far East), depending on a 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.

Investigator & Site Selection

Good selection, management and assistance are vital to a study’s outcome. Opera provides can provide experienced investigators and gives recommendations based upon past experience with reputable institutions suitable to your study requirements.

Reporting & Medical Writing

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 a higher probability of success.

Clinical Monitoring

The highest quality review of data and effective interaction with study sites are the top priorities of our clinical operation team during on-site monitoring visits.

Clinical Trials 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.

Data Management & Statistics

To ensure generation of high-quality, reliable, and ready to be statistically analyzed data, our data management unit is involved from the beginning to the completion of a clinical trial.

THERAPEUTIC AREAS

Oncology & Haematology

Oncology trials can have a large time span with a long term and varied follow-up period. To better conduct oncology studies, make use of our multi-disciplinary team and project management skills.

Psychiatry

Our team is exceptionally familiar with diagnostic tools and outcome measures to evaluate a broad spectrum of psychiatric disorders.

AIDS

Among infectious diseases, Opera has remarkable affinity with trials in the HIV/AIDS field.

Paediatrics

Naturally, clinical studies involving medication aimed at children requires increased ethical review and caution. Needless to say, Opera's clinical development in children goes the extra mile in safety measures.

Metabolic

The endocrinology field, and diabetes specifically, is extremely competitive with many available centers that can be selected. Opera makes use of this to increase cost-effectiveness for our clients.

AND THE RANGE

OF OUR EXPERTISE

Medical Devices

With the new MDR, there is an increased need for Clinical Evidence. Opera can help generate this making use of our experience.

In Vitro Diagnostics

After implementation of the MDR, IVDR will be the next challenge in our industry. Opera can already help you prepare to be IVDR compliant and secure your market position.

Small Molecules

Seemingly less newsworthy than biologics and ATMP therapies, small molecules still make up the majority of drugs on the market, and small molecule research is regarded to be on the rise.

Biologicals & Vaccines

Every biologic molecule and every vaccine is uniquely developed. At Opera, we make sure that your clinical trial is tailored to your candidate.

Gene Therapies

A knowledgeable partner that can support your required methodology is key in gene therapy trials. Contact us to hear more about specific experience and technology available for these trials.