GCP Protocol and SOP Training

 

The BRCR Global staff is required to have sufficient training and level of preparation and expertise to understand and perform all tasks related to their work in a logical and orderly manner.

 

The training should cover all aspects related to a study, including the detection and registration of patients, and the finalization, presentation and correction of all data forms.

 

Each Director has the responsibility, as established in the organizational chart, to communicate the objectives in a clear, timely and effective manner, in order to ensure compliance with the goals assigned to each BRCR Global`s Partners.

All BRCR Global partners must sign confidentiality agreements.

The Department of BRCR GLOBAL QA will be in charge of the administration of its training system, which should cover a variety of training categories to ensure that all members of BRCR Global have the same level of skill and knowledge necessary to carry out their work responsibilities.

 

The site staff is trained to run online reports on the status of queries, and can view cumulative summaries of data for each of their patients all time.

 

We provide all the support that our staff requires to develop and enhance the skills required for their daily performance.


• THEORICAL REVIEW
GCP/ ICH GUIDELINES review, PROTOCOL review, internal SOP review


• HANDS-ON SCENARIOS
Enrollment scenarios, regulatory packets completion, source templates creation, IP logs completion, filing, subject visit scenarios.

 

• WEEKLY TRAINING SESSIONS
Staff meeting including protocol specific training.


• SOP CREATION

New SOP documents, amendments to previous SOPs based on FDA inspections/ Sponsor audits/monitoring visits reports.

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.

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We have extensive experience in a variety of therapeutic areas by managing studies in USA, Latin America, Caribbean Islands and Central America. We have built strong business relationships with main researchers in several cities in the referred regions.

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Locations

Plantation, USA
Headquarters

8200 W Sunrise Blvd Suite D2
Phone: 001 561 447 0614
FL 33322

CDMX, Mexico

Sur 132 No. 108 Suite 601-605 Col. Las Americas CP 01120
Phone: 52(55) 2614 5118
52 1 55 733805117

Guayaquil, Ecuador

Cdla. Los Ceibos, Los Olivos 3, Av. Leopoldo Carrera Calvo #103 y calle 15va Edif, EBC
Phone: +593 04 507 5777

Costa Rica

Ctro. Cultural Los Yoses, 200 mts norte 50 mts este. Barrio Dent. Edif Ofident. San Jose.
Phone +506 4800 0254

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