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