BTrials 360 EN

BTrials 360 EN

TOOLS AND SOLUTIONS
FOR CLINICAL RESEARCH

BTRIALS 360º
Service Management Organization

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MISSION

                     To help Sponsors, CRO´s and Clinical Research Centers achieve their goals quickly and effectively, ensuring high standards of quality

VISION

To be the main provider of services for the development of clinical research  in Latin America

VALUES

FOCUS ON CLIENT

The understanding of our clients’ needs and the collaborative work with them, allow us to ensure the fulfillment of their goals. Our flexibility and search for solutions that add value to our clients, allows us to build long-lasting relationship with them.

TEAM WORK

Good results are a consequence of cooperation and support of each of our professionals, who see challenges as opportunities for development.

RESPONSIBILITY

Science development implies commitment and responsibility, where compliance with Good Clinical Practice is the basis for the care of patients, clients, and collaborators.

INNOVATION

Our entrepreneurial spirit encourages us to constantly search for new initiatives and solutions for Clinical Research.

SERVICES

CLINICAL TRIALS

 

  • Planning with Sponsor/CRO

 

  • Trial design

 

  • Submissions to the Ethics Committee and Regulatory Authority

 

  • Operational development of trial protocol

 

  • Trial closure

 

 

RESEARCH CENTERS NETWORK

 

  • Multidisciplinary research Centers
    • Identification of potential investigators and research centers

 

  • High recruitment rate

 

  • Efficient in monitoring costs

 

  • Experience in audits and inspections

CRO

 

  • Administrative-regulatory assistance
    • Feasibilities
    • Communication with sponsor / CRO
    • Regulatory document management to the Ethics Committee
    • Start-Up
    • Importation License
    • Submission and notifications to the Regulatory Authority during the conduction of the clinical trial
    • Translation of the informed consent form (ICF) and translation validation
    • Startup of the center and closing operations of the center
  • Clinical monitoring
  • Pharmacovigilance/Technovigilance
  • Reporting of SAEs to the sponsor/CRO, Ethics Committee, and Regulatory Authority
  • Statistical analysis
  • Advise on contract negotiation process with the Sponsor
  • Advise on Data Entry (Resolution of queries according to trial requirements)
  • Document filing and maintenance
  • Advise on quality source documentation and trial procedures, pre monitoring
  • Source document preparation based on trial (Worksheets, Quality Documents, etc.)

SMO

 

  • Training for investigators in Good Clinical Practice
  • Promote the research center within the Pharmaceutical Industry
  • Advise on contract negotiation process with the Sponsor/CRO
  • Outsourcing – Clinical trial coordination
  • Clinical Trial Protocol Compliance
    • Ensure protocol compliance – Adherence to GCP
    • Advise and alert researchers about possible protocol deviations
    • Advise and alert researchers about possible ICH-GCP deviations
  • Reporting of SAEs to the sponsor/CRO, Ethics Committee, and Regulatory Authority
  • Recruitment
  • Advise investigators on patient follow-up and retention activities
  • Source document preparation based on trial (Worksheets, Quality Documents, etc.)
  • Implementation of the LEAN system methodology for process optimization
  • Advise on quality source documentation and trial procedures, pre monitoring
  • Advise on Data Entry (resolution of queries according to trial requirements)

THERAPEUTIC AREAS

  • CARDIOVASCULAR
  • DERMATOLOGY
  • MEDICAL DEVICES
  • PAIN
  • ENDOCRINE/METABOLIC DISORDERS
  • AUTOIMMUNE DISEASES
  • GASTROENTEROLOGY
  • HEMATOLOGY
  • INFECTOLOGY
  • NEPHROLOGY
  • NEUROLOGY
  • ONCOLOGY
  • RESPIRATORY DISORDERS
  • RHEUMATOLOGY
  • VACCINATIONS

OUR STRATEGIC PARTNERS

LOCATION

Address: Dr. Manuel Barros Borgoño 71, Office 1407, Providencia District, Santiago, Chile

BTRIALS 360º – Tools and solutions at the service of Healthcare

contacto@btrials.com    +56 9 3192 0260    +56 9 6300 3166