FOR SPONSORS OR CRO´S

It is well known that time is most critical in clinical trials. The sooner pharmaceutical can complete a study, the sooner they will gain faster approval.

Options to conduct Trials in the US, Latin America or Both.

Boca Raton Clinical Research Global can help your company meet its timelines in the following areas:

- Experienced project managers who will  understand SPONSOR’S protocol.

- Rapid Site identification and qualification

- Feasibility  Analysis: PI or Sites’s Capabilities & Infrastructure, Personnel ,Competing Clinical Trials, Patient population.

- Study Start Up

- Prompt contract and budget negotiation  (one contact for all contracts and budgets)

- Rapid, right first time regulatory documentation completion (centrally coordinated)

- IRB/MOH submissions and approvals.

- Ensure the quality of submissions

- Global regulatory knowledge needed to effectively facilitate communication with regulatory agencies and anticipate and resolve potential challenges.

- Regulatory review of essential documents, internal and external auditing as well as participation in audits, management of and surveillance program and regulatory consulting.

- Ensure protocol compliance.

- Minimal time spent monitoring high quality, professional sites

- Reporting serious adverse events to the Sponsor or CRO and the IRB/IEC.

- Advising & alerting investigators of potential protocol violations.

- Advising & alerting investigators of potential ICH-GCP violations.

- Facilitate patient selection, enrollment, randomization and retention.

- Recruitment & Retention team focused on qualified subjects.


BRCR Global
associates understand the regulations and customs of the countries in which we operate. This knowledge allows us to develop and quickly implement appropriate patient recruitment strategies, including advertising tailored for local audiences.

Diverse patient populations including minority Groups, treatment naïve, hospitalized, and difficult study indications.

Graphic designers with expertise in media creation specifically for clinical trials.

Bilingual Call Center dedicated to recruitment & retention for clinical trials

Patient Retention: Follow-up by our call center to ensure study compliance and answer patient inquiries.

Trial-related documents archival and maintenance

Trial closeout operations


PATIENT REGISTRATION

Boca Raton Clinical Research follows HIPAA Guidelines and maintains patient confidentiality. Patient registration, medical history, family history and trial participation is stored in our patient database and is never shared or sold