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

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 of like trial information

III.Provide patient/site/month recruitment estimates

IV.Identity issues related to the recruitment projections

V.Review the competitive regional and global landscape

Cro Clinical ResearchSTUDY START-UP

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

II.Clinical Development Plans (PM, Monitoring, Quality, Communication, etc)

III.Final Investigator/site selection & patient recruitment strategies

IV.Preparation and conduction of Kick off meeting.

V.Investigator Meeting Planning and execution

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

CRO Contract Research OrganizationCLINICAL PROJECT MANAGEMENT

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

II.Project tracking (Patient screening and randomization, Site Monitoring)

IIi.Vendor Management

IV.Management of Drug/Device supply, laboratories and local couriers

V.Local and Central safety management

VI.Communication with Investigator, Site, Sponsor and Vendor (TC, F2F, internal project meetings)

CRO ResearchREGULATORY AFFAIRS DEPARTMENT

I.Advice on Regulatory procedures where the operation is requested

II.Site Regulatory Files management

III.Ethics committee submissions

IV.Management of IRB documents and operations

V.Local and Regional Regulatory Agency approvals

VI.Preparation of country specific product labels for IP

VII.Import /Export licenses & customs advice

Clinical Research ServicesREAL WORLD EVIDENCE & LATE PHASE

ACTIVACRO offers 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:

I.Retrospective chart review

II.Database study

III.Real world evidence (RWE)

IV.Late phase randomized clinical trials (phase IV interventional, none interventional and registry)

V.Observational epidemiologic studies

VI.Registry studies

VII.Post-authorization safety studies

VIII.Health economics and outcomes research

Clinical Research OrganizationBIOEQUIVALENCE & BIOAVAILABILITY STUDIES

ACTIVACRO offers a core capabilities to help our clients to achieve their scientific and commercial objectives.
A highly qualified team leads our Bioequivalence department with years of experience in the area:

I.Coordinate the process with “Qualified” partners located in the main reference's countries (Argentina, Brazil, Mexico, Colombia) which a MSA is in-placed

II.Availability to expand the operation to other countries of the region through identified Bioequivalence units which need to be qualified

III.Collaborate with all aspect of the process

Protocol Writing
Sample Size Calculation and Statistical method
Informed Consent
Statistical Analysis and report
Study Reports

Cro PharmaMEDICAL AFFAIRS DEPARTMENT

I.Responsible in conjunction with Clinical Operations of all Regional Pharmacovigilance activities

II.Receiving/Processing/Archiving adverse events

III.Interaction with Sponsor´s or regulatory authorities PVG operative áreas

IV.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

Cro Clinical ResearchMEDICAL WRITING DEPARTMENT

I.Protocol / Sample Size Calculation

II.Informed Consent

III.Clinical Investigator Brochure

IV.Clinical Study Reports

V.Publications

CRO Contract Research OrganizationDATA MANAGEMENT DEPARTMENT

I.Data Base design

II.CRF design

III.IWRS

IV.Biostatistics

CRO ResearchCLINICAL STAFFING SOLUTIONS

I.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

II.Customized employment service solutions in the following areas:

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

Clinical Research ServicesQUALITY ASSURANCE SERVICES

I.Conduct of quality GCP audits

II.Conduct of contract vendor/supplier audits

III.Conducts internal (staff) and external (sites) GCP training

IV.Development of Quality Plans, Quality Manuals, SOPs and SQP’s

V.Operational Headquarters successfully audited by sponsors

VI.Quality assurance auditors certified globally with experience in Us, Europe , Asia and Latin America

Clinical Research OrganizationLEGAL 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 ACTIVACRO to:

I.Represent sponsor for Ministry of health Trial Approval

II.Represent sponsor at local/central EC´s and IRB´s


III.Represent sponsor for importation purposes

OUR OFFICES