The Clinical Project Manager is the key point of contact between Sponsors and ACTIVA CRO.
The CPM is accountable for:
– Documentation updates and maintenance
– Project tracking
– Vendor Management
– Logistic and Depot Management
– Laboratory Management (sample storage)
– Local and Central safety management
– Communication with Investigator, Site, Sponsor and Vendor
– Inspection Readiness and mitigation planning
ACTIVA CRO works to keep the sites and TMF ready to be inspected at any time following a continuous, ongoing program that requires a commitment to steadily maintaining high-quality, GCP-compliant processes and deliverables.
Based on our Quality Management System, ACTIVA CRO develops an annual Quality Plan which is reviewed periodically to update in case issues are detected.
The site quality maintenance and tracking (Issues and CAPA management Plan) is inspired in our SOPs.
Apart of the Site Monitoring, the following activities are regularly implemented:
– Quality Check of the Investigator Site File (ISF)
– Quality Check of the eTMF
– Site preparation in the case of Inspection
ACTIVA CRO counts on an experienced team to coordinate the Regulatory Start-up process in Latin America. The Regulatory Affair Manager is the main point of contact for the project initiation.
ACTIVA CRO provide a detailed essential document analysis to determine:
– Best strategies for approaching the Regulatory Agencies
– Preparation and Submission of regulatory package to Ministry of Health (MoH)
– Preparation and Submission of regulatory package to Ethic Comities and IRBs
– Import / Export license application
This service provides Sponsors, not present in the region, with a legal entity for the conduction of Clinical Trials in Latin America.
The scopes of the legal representation is documented with a Power of Attorney which enabling ACTIVA CRO to act as the sponsor for:
– Submission of regulatory package to Ministry of Health (MoH)
– Submission of regulatory package to Ethic Comities and IRBs
– Import of Records
– Sign contracts with investigators and vendors
ACTIVA CRO has vast experience in contract management with investigators and sites gained by years, our legal knowhow speed the process saving regulatory time.
The scopes are related with:
– Investigator contract template development and negotiation
– Investigator budget development and negotiation
– Contract execution
ACTIVA CRO could collaborate with the sponsor providing the following services:
– Conduct of quality GCP audits
– Conduct of contract vendor/supplier audits
– Conducts internal / external GCP training
– Development of Quality Plans and Quality Manuals for a specific project
– Auditors certified globally with experience in US, EU, APAC and LATAM
ACTIVA CRO provides support to the Sponsor in all aspects related to medical / scientific advisory. We can collaborate with the Project offering high qualified physician who speak the local languages to cover the following critical areas:
– Medical Monitoring
– Medical Liaison
– Pharmacovigilance
ACTIVA CRO collaborate facilitating the hiring of high quality 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 and provide backups in the case of
need
– Customized employment service solutions in the following areas:
> Project Manager (CPM) / Monitors (CRAs) / Assistant (CTA)
> Regulatory Affairs
> Medical Affairs
> Study Coordinators
ACTIVA CRO provide a project analysis to generate in collaboration with the SPONSOR:
– Study plans and guidelines
– Implement process tailored for a specific project
– Patient recruitment strategies
– Patient Retention policies
– Identify training needs and train the team and sites
– Identify vendors to collaborate with the study
– Kick-off meeting
– Investigator / CRA meeting
ACTIVA CRO will perform a detailed project analysis to identify and recommend the SPONSOR of:
– Best countries, Investigators and Sites for conducting a Clinical Trials
– Strategies for developing the Project based on the incidence/prevalence of a
disease, regulatory timelines, and recruitment profile.
– Enrollment Projections and anticipate possible issues
– Overall Implementation costs
– Review the competitive regional and global landscape
ACTIVA CRO maintain high-quality standards based on performing the following activities:
– Investigator and site identification, selection and qualification
– Site Initiation, routine monitoring and close out visits
– Site management
– Site staff continuous training
– Source data verification
– Trial Master File maintenance and update