STUDY FEASIBILITY
STUDY START-UP
CLINICAL PROJECT MANAGEMENT
REGULATORY AFFAIRS DEPARTMENT
REAL WORLD EVIDENCE & LATE PHASE
BIOEQUIVALENCE & BIOAVAILABILITY STUDIES
MEDICAL AFFAIRS DEPARTMENT
MEDICAL WRITING DEPARTMENT
CLINICAL STAFFING SOLUTIONS
QUALITY ASSURANCE SERVICES
LEGAL SPONSOR REPRESENTATION
STUDY FEASIBILITY
STUDY FEASIBILITY
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
STUDY START-UP
STUDY 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
CLINICAL PROJECT MANAGEMENT
CLINICAL PROJECT MANAGEMENT
- Continuous Regulatory documentation updates and maintenance in accordance with country specific requirements
- Project tracking (Patient screening and randomization, Site Monitoring)
- Vendor Management
- Management of Drug/Device supply, laboratories and local couriers
- Local and Central safety management
- Communication with Investigator, Site, Sponsor and Vendor (TC, F2F, internal project meetings)
REGULATORY AFFAIRS DEPARTMENT
REGULATORY AFFAIRS DEPARTMENT
- Advice on Regulatory procedures where the operation is requested
- 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
- Import /Export licenses & customs advice
REAL WORLD EVIDENCE & LATE PHASE
REAL WORLD EVIDENCE & LATE PHASE
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:
- 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
BIOEQUIVALENCE & BIOAVAILABILITY STUDIES
BIOEQUIVALENCE & BIOAVAILABILITY STUDIES
- Coordinate the process with “Qualified” partners located in the main reference’s countries (Argentina, Brazil, Mexico, Colombia) which a MSA is in-placed
- Availability to expand the operation to other countries of the region through identified Bioequivalence units which need to be qualified
- Collaborate with all aspect of the process
- Protocol Writing
- Sample Size
- Calculation and Statistical method
- Informed Consent
- Statistical Analysis and report
- Study Reports
MEDICAL AFFAIRS DEPARTMENT
MEDICAL AFFAIRS DEPARTMENT
- Responsible in conjunction with Clinical Operations of all Regional Pharmacovigilance activities
- Receiving/Processing/Archiving adverse events
- Interaction with Sponsor´s or regulatory authorities PVG operative áreas
- 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
MEDICAL WRITING DEPARTMENT
MEDICAL WRITING DEPARTMENT
- Protocol / Sample Size Calculation
- Informed Consent
- Cro Clinical Investigator Brochure
- Clinical Study Reports
- Publications
CLINICAL STAFFING SOLUTIONS
CLINICAL STAFFING SOLUTIONS
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
QUALITY ASSURANCE SERVICES
CLINICAL STAFFING SOLUTIONS
- 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
- Quality assurance auditors certified globally with experience in Us, Europe , Asia and Latin America
LEGAL SPONSOR REPRESENTATION
CLINICAL STAFFING SOLUTIONS
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:
- Represent sponsor for Ministry of health Trial Approval
- Represent sponsor at local/central EC´s and IRB´s
- Represent sponsor for importation purposes
