Activa Cro

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Activa Cro is a Regional Contract Research Organization operating in Latin America, that provides clinical research services to the pharmaceutical, biotechnology and medical device/diagnostic industry in Argentina, Brazil, Chile, Colombia, México, Panama, Perú, Ecuador and Uruguay.

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http://www.activa-cro.com/
Activa Cro
Type Private
Industry Pharmaceuticals
Founded 2003
Headquarters Av. Santa Fe 1592, 3rd Floor, C1060ABO

Ciudad Autónoma de Buenos Aires, Argentina

Number of employees 51-200

GEOGRAPHICAL COVERAGE

Since 2003, Activa Cro provided its services throughout the Latin America encompassing 90% of the clinical research market.

STRENGTH

  • Regional Regulatory & Operational expertise
  • Streamlined regulatory procedures ensuring faster Start-Up times
  • PI Network combining opinion Leaders and High recruiters

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.

STUDY 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

STUDY 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

REGULATORY 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

REGIONAL PHARMACOVIGILANCE

• Receiving/Processing/Archiving adverse events in countries of operation • Medical monitoring • Ethics committee /IRB & MOH submissions • Ensure compliance with local & International requirements

LOCAL 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 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 courier • Local and Central safety management  • Communication with sites, sponsor and vendors (TC, FtoF, internal project meetings)

QUALITY 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 

OTHER 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

History

Activa Cro is a full-service contract research organization (CRO) with operations in Latin America, that provides the biotechnology, pharmaceutical and medical device industry, with a range of services related to clinical development of health products.

The company was founded in 2003, in Buenos Aires, Argentina and rapidly expanded to Chile in 2004 and Uruguay a couple of years later (2007) becoming a “southern cone” provider.

In 2008 Activa Cro started operations in México DF, and finally Brazil, Perú, Colombia and Panamá was added to the scope of LA countries, conforming a true “regional” CRO.

Activa Cro brings today an experience of more than 50 projects in all clinical phases of development and major therapeutic indications, including Oncology, Hematology, Cardiovascular, Orphan Diseases, CNS, First in Human and Pivotal studies in Medical Devices, with senior project managers that bring an average of 10 years of experience in clinical research operations.

Activa Cro remains and presents itself as a “boutique” CRO, offering personalized products and services.

We endeavor to satisfy our “clients & partners” requirements and expectations, by “working closely” with them to facilitate the efficient management of their projects and the success of our business partnerships.

References

  1. http://www.activa-cro.com/

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