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 ResearchLegal Sponsor Representation

This service provides Sponsors -not present in the region- with a legal entity for the conduction of clinical trials in Latin America, 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

Represent sponsor in any legal proceedings (legal council fees not included in this service)

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 OrganizationMedical Affairs

Responsible in conjunction with Clinical Operations of all Regional Pharmacovigilance activities
Receiving/Processing/Archiving adverse events in countries of operation
Interaction with Sponsor´s and/or regulatory authorities in pharmacovigilance
Medical Monitoring activities throughout the lifetime of clinical studies:

Aid in study design of the key clinical documents
Review safety monitoring plan
Frequent calls to investigators throughout trial
Assist sites with inclusion/exclusion criteria questions
Assess need for protocol amendments in conjunction with the sponsor
Review of lab reports, safety reports, and protocol deviations
Produce narrative of SAEs if requested

Contract Research OrganizationReal World Evidence and Late Phase

We offer a core capabilities to help our clients to achieve their scientific and commercial objectives. A highly qualified team who leads our Real World Evidence (RWE) and Late Phase Research efforts with years of clinical, observational, and economic research experience:

Retrospective chart review
Database study
Real world evidence (RWE)
Late phase randomized clinical trials (phase IV interventional, none interventional and registry)
Observational epidemiologic studies
Registry studies
Post-authorization safety studies
Health economics and outcomes research

Contract Research OrganizationClinical Staffing Solutions

We offer a customized employment service solutions in the following areas:

Project Manager (CPM)/ Monitors (CRAs)/ Asistant (CTA)
Study Coordinators
Regulatory Affairs
QA/Compliance auditors
Medical Affairs functions

We facilitate the hiring of high performing professionals in specialty niche positions by:

Creating a customized job description that fits your project requirements
Recruiting from our vast network of industry professionals
Conducting competitive screening
Presenting profiles of qualified candidates
Facilitating the offer, acceptance and onboarding processes

Contract Research OrganizationData Management

Data base design
CRF design
IWRS
Biostatistics