I. Analysis on protocol in order to determine

  • Best country, PI, Site to conduct a Cro Clinical Trials
  • 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


  1. I. Advice on Study Design, Protocol ,ICF & CRF/eCRF development
  2. II. Clinical Development Plans (PM, Monitoring, Quality, Communication, etc)
  3. III. Final Investigator/site selection & patient recruitment strategies
  4. IV. Preparation and conduction of Kick off meeting.
  5. V. Investigator Meeting Planning and execution
  6. VI. Timely submission of regulatory Dossiers to IRB’s/ECs/MOH to ensure the lowest timeframe from study set-up to FPI


  1. Continuous Regulatory documentation updates and maintenance in accordance with country specific requirements 
  2. Project tracking (Patient screening and randomization, Site Monitoring)
    1.  Vendor Management
  3.  Management of Drug/Device supply, laboratories and local couriers
  4. Local and Central safety management
  5. Communication with Investigator, Site, Sponsor and Vendor (TC, F2F, internal project meetings)


  1. Advice on Regulatory procedures where the operation is requested 
  2. Site Regulatory Files management
  3. Ethics committee submissions
  4.  Management of IRB documents and operations
  5. Local and Regional Regulatory Agency approvals
  6.  Preparation of country specific product labels for IP
  7.  Import /Export licenses & customs advice


We offer 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:

  1. Retrospective chart review
  2. Database study
  3. Real world evidence (RWE)
  4. Late phase randomized clinical trials (phase IV interventional, none interventional and registry)
  5. Observational epidemiologic studies
  6. Registry studies
  7. Post-authorization safety studies
  8. Health economics and outcomes research


  1. Coordinate the process with “Qualified” partners located in the main reference’s countries (Argentina, Brazil, Mexico, Colombia) which a MSA is in-placed
  2. Availability to expand the operation to other countries of the region through identified Bioequivalence units which need to be qualified
  3. Collaborate with all aspect of the process
  • Protocol Writing
  • Sample Size
  • Calculation and Statistical method
  • Informed Consent
  • Statistical Analysis and report
  • Study Reports


  1. Responsible in conjunction with Clinical Operations of all Regional Pharmacovigilance activities
  2. Receiving/Processing/Archiving adverse events
  3. Interaction with Sponsor´s or regulatory authorities PVG operative áreas
  4. 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


  1. Protocol / Sample Size Calculation
  2.  Informed Consent
  3.  Cro Clinical Investigator Brochure
  4.  Clinical Study Reports
  5.  Publications


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

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


  1. Conduct of quality GCP audits
  2. Conduct of contract vendor/supplier audits
  3. Conducts internal (staff) and external (sites) GCP training
  4. Development of Quality Plans, Quality Manuals, SOPs and SQP’s
  5. Operational Headquarters successfully audited by sponsors
  6. Quality assurance auditors certified globally with experience in Us, Europe , Asia and Latin America


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:

  1. Represent sponsor for Ministry of health Trial Approval
  2. Represent sponsor at local/central EC´s and IRB´s
  3. Represent sponsor for importation purposes

We are dedicated to providing innovative solutions and high-quality services to our clients in the healthcare industry. With our expertise and commitment to excellence, we aim to be your trusted partner in achieving your research and sourcing goals.

We are at:

133 New Bridge Road #10-03
China Town Point, Singapore (059413)

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