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EXPERIENCES

"The only source of knowledge is experience."
Albert Einstein

Experiences

Recruiting study participants is arguably the most critical part of the clinical trial process, but it's also one of the most challenging. Strategic preparation is vital to the successful recruiting and enrolling of qualified participants on a clinical trial.

We often exceed expectations: Previously, as part of a diabetes study which required 100 eligible patients for a free public diabetes test in a shopping mall on a weekend, MIRA projects managed to enrol 105.

In our previous projects, we managed multiple sites with the utmost efficiency. These sites were contacted periodically and supported on strategies for high patient recruitment.

We have extensive experience in project management as the following:

Owing to our experience and competence we create accurate budget proposals for EU and non-EU countries such as Hungary, Poland, Czechia, Serbia, Russia, and Turkey. We have extensive experience in preparing and negotiating Clinical Trial Agreements, amendments and vendor contracts as well as satisfying customer requirements in terms of time and cost management. We manage this process in cooperation with a designated legal team.

Leading the CRA team of multi-studies and/or multi-sites in different stages and phases.

We contribute to SOPs, E-archiving, document filing as well as transitioning of studies, and acting as key contact of the leads for the international CROs.

We perform investigative archiving, and site file reconciliation upon request of any new or updated site-related essential and non-essential documents.

We assess all the above-mentioned documents for content, consistency, and compliance with local regulatory requirements, ICH guidelines, and project Standard Operating Procedures (SOPs).

We can recruit dedicated CRAs and train them according to sponsor-specific needs. Alternatively, we can build an experienced CRA team in various clinical trials in different phases and stages and supervise them on behalf of the sponsors.

We provide CRA and Investigator training, including but not limited to Basic and Advanced CRA training, Team Building, Monitoring and GCP training.

We organise Investigator Meeting events with multinational participants. This service includes booking flights, accommodation, and meeting rooms, as well as arranging transfers. We also prepare meeting sessions with all the necessary equipment.