Activa CRO-Contract Research Organization Contract Research Organization

OUR AIM IS TO BE THE LEADING REGIONAL CRO
IN LATIN AMERICA.

"We offer complete services in the field of clinical research. Design of study documents, selection and management of investigational sites, subject recruitment , project management and monitoring services."

CLINICAL RESEARCH SERVICES

Activa Cro offers full service in the field of Clinical research, bringing outsourcing solutions to the Pharmaceutical, Drug, Biological and Device Industry.

Cro PharmaSTUDY FEASIBILITY

Activa Cro process includes

I.Analysis on protocol in order to determine

• Best country, PI, Site to conduct a Clinical Trial
• Enrollment Projections
• Overall costs

II.Check up/comparison with Historical database

III.Provide patient/site/month recruitment estimates

Cro Clinical ResearchSTUDY START-UP

• Advice on Study Design, Protocol, ICF & CRF/eCRF development

• Clinical Development Plans (PM, Monitoring, Quality, Communication, etc)

• Final Investigator/site selection & patient recruitment strategies

• Preparation and conduction of Kick off meeting.

• Investigator Meeting Planning and execution

• Timely submission of regulatory Dossiers to IRB’s/ECs/MOH to
  ensure the lowest timeframe from study set-up to FPI

CRO Contract Research OrganizationREGULATORY AFFAIRS

• Advice on Regulatory procedures in countries of operation

• Site Regulatory Files management

• Ethics committee submissions

• Management of IRB documents and operations

• Local and Regional Regulatory Agency approvals

• Preparation of country specific product labels for IP and Concomitant Medication/s

• Import /Export licenses & customs advice

CRO ResearchREGIONAL PHARMACOVIGILANCE

• Receiving/Processing/Archiving adverse events in countries of operation

• Medical monitoring

• Ethics committee /IRB & MOH submissions

• Ensure compliance with local & International requirements

CRO ClinicalLOCAL PROJECT COORDINATION

This service provides sponsors/clients with legal representation in Latin America,
for the conduction of a clinical trial enabling Activa Cro to:

• Execute contracts with PI, sites & vendors on behalf of the client

• Administrate PI and vendor grants

• Represent sponsor for Ministry of health Trial Approval

• Represent sponsor at local/central EC΄s and IRB΄s

• Represent sponsor for importation purposes

• Activa will always ask for sponsor΄s specific approval before proceeding

Clinical Research ServicesCLINICAL TRIAL MANAGEMENT

Activities involving Ongoing Trial Management:

• Continuous Regulatory documentation updates and maintenance in accordance
  with country specific requirements

• Patient screening and randomization

• Site Monitoring

• Project tracking

• Management of Drug/Device supply, laboratories and local couriers

• Local and Central safety management

• Communication with sites, sponsor and vendors (TC, FtoF, internal project meetings)

Clinical Research OrganizationQUALITY ASSURANCE SERVICES

• Conduct of quality GCP audits

• Conduct of contract vendor/supplier audits

• Conducts internal (staff) and external (sites) GCP training

• Development of Quality Plans, Quality Manuals, SOPs and SQP’s

• Operational Headquarters successfully audited by sponsors

First regional CRO certificated in “Control & Surveillance on Clinical Research Trial Processes by ISO

Contract Research OrganizationOTHER CAPABILITIES

Other clinical services outsourced or in house include:

• Medical Writing
• Data Management
• Clinical Staffing Solutions
• CRF/eCRF Development
• Biostatistics
• FIH Device studies
• CRA/CTA outsourcing