Clinical Research Services
Training:
Design and delivery of tailored training courses covering all
aspects of clinical research and clinical trial regulations. Face
to face or multimedia e-learning formats, customized to sponsor
requirements.
On-the-field coaching for new monitors
LeadCRAs / PMs: personalized leadership programs.
Quality:
GCP audits: Domestic and International Clinical Research Trial
audits. We provide the full audit report plus a strategic plan to
address findings.
Co-Monitoring activities: co-monitoring visits for investigator
sites, vendors, study files or Investigator Site files.
SOPs development / revision: assist in developing and/or
reviewing / revising SOPs for the clinical research area in
accordance with GCP and client needs.
Inspection readiness: preparation for upcoming external audits
or regulatory agency inspections for sites and company affiliates
Guidance for responding warning letters, audit / inspection
reports.
Pharmacovigilance Services
Our company offers to satisfy the needs of the pharmaceutical companies
by providing integral Pharmacovigilance (PVG) services and risk management
solutions concerning marketed medicinal products on a challenging regulatory
framework in Latin America.
Individual Case Safety Report (ICSR) Management:
Case information collection from any source type (e.g. spontaneous,
observational studies, etc.)
Case processing in Jazz® (our Drug Safety Database
- web system) or in the Client's database
Triage and coding of medical terminology (MedDRA)
Case narrative
Medical assessment of single cases
Statistical reports for the Client on case processing
and reporting (on a monthly basis)
Development and analysis of aggregate reports
Regulatory Services and Medical Writing:
Implementation of the local PVG legislation requirements.
Case reporting: preparation and submission of customized safety reports
to the local Health Authority (in accordance to local requirements)
Preparation and submission of Periodic Safety Update Reports
(PSUR/PBRER) to the local Health Authorities
Development of Risk Management Plans (RMP) / Risk Assessment
Signal Management & Risk Assessment:
Development and implementation of Product Surveillance Plans
Signal management and product information review
Benefit-risk assessment and support on safety issue management
(e.g. communication to Regulatory Authorities and/or health professionals)
Medical support for decision making in labeling update
Development and implementation of risk minimization strategies
Post Marketing Surveillance & Patient Support programs:
Program and e-CRF design for PVG monitoring programs (e.g.
intensive PVG programs) and observational studies (e.g.
post-authorization safety studies (PASS) and others)
Statistical analysis, preparation and submission of the final report
Implementation of Patient Support Programs, as per Client needs
Training activities:
Elaboration and conduction of PVG training programs (e.g. interactive
workshop on PVG regulatory requirements)
Basic and advanced training on PVG topics "in house"
(face-to-face or by videoconference) or through e-learning
Training material preparation and recording
Training plan development
Quality Management System:
Implementation of a Local PVG and Quality System
Preparation and update of Standard Operating Procedures,
Working Instructions, Policies and Guidelines
Preparation and maintenance of the Pharmacovigilance System
Master File and Business Continuity Plan
Quality Monitoring Visits - Audit preparation
Implementation and follow up of CAPAs
Inspection readiness/support for PV topics
Other PVG Services:
Local scientific literature screening: systematic literature searches & review
Medical Information (including specialized Call Center support)
Pharmacovigilance Agreements
Training:
Design and delivery of tailored training courses covering all aspects of clinical research and clinical trial regulations. Face
to face or multimedia e-learning formats, customized to sponsor
requirements.
On-the-field coaching for new monitors LeadCRAs / PMs: personalized leadership programs. Quality:
GCP audits: Domestic and International Clinical Research Trialaudits. We provide the full audit report plus a strategic plan to
address findings.
Co-Monitoring activities: co-monitoring visits for investigatorsites, vendors, study files or Investigator Site files.
SOPs development / revision: assist in developing and/orreviewing / revising SOPs for the clinical research area in
accordance with GCP and client needs.
Inspection readiness: preparation for upcoming external auditsor regulatory agency inspections for sites and company affiliates
Guidance for responding warning letters, audit / inspection
reports.
Pharmacovigilance Services
Our company offers to satisfy the needs of the pharmaceutical companies
by providing integral Pharmacovigilance (PVG) services and risk management
solutions concerning marketed medicinal products on a challenging regulatory
framework in Latin America.
Individual Case Safety Report (ICSR) Management:
Case information collection from any source type (e.g. spontaneous,observational studies, etc.)
Case processing in Jazz® (our Drug Safety Database - web system) or in the Client's database
Triage and coding of medical terminology (MedDRA) Case narrative Medical assessment of single cases Statistical reports for the Client on case processing and reporting (on a monthly basis)
Development and analysis of aggregate reportsRegulatory Services and Medical Writing:
Implementation of the local PVG legislation requirements. Case reporting: preparation and submission of customized safety reportsto the local Health Authority (in accordance to local requirements)
Preparation and submission of Periodic Safety Update Reports (PSUR/PBRER) to the local Health Authorities
Development of Risk Management Plans (RMP) / Risk AssessmentSignal Management & Risk Assessment:
Development and implementation of Product Surveillance Plans Signal management and product information review Benefit-risk assessment and support on safety issue management(e.g. communication to Regulatory Authorities and/or health professionals)
Medical support for decision making in labeling update Development and implementation of risk minimization strategiesPost Marketing Surveillance & Patient Support programs:
Program and e-CRF design for PVG monitoring programs (e.g. intensive PVG programs) and observational studies (e.g.
post-authorization safety studies (PASS) and others)
Statistical analysis, preparation and submission of the final report Implementation of Patient Support Programs, as per Client needsTraining activities:
Elaboration and conduction of PVG training programs (e.g. interactiveworkshop on PVG regulatory requirements)
Basic and advanced training on PVG topics "in house"(face-to-face or by videoconference) or through e-learning
Training material preparation and recording Training plan developmentQuality Management System:
Implementation of a Local PVG and Quality System Preparation and update of Standard Operating Procedures,Working Instructions, Policies and Guidelines
Preparation and maintenance of the Pharmacovigilance SystemMaster File and Business Continuity Plan
Quality Monitoring Visits - Audit preparation Implementation and follow up of CAPAs Inspection readiness/support for PV topicsOther PVG Services:
Local scientific literature screening: systematic literature searches & review Medical Information (including specialized Call Center support) Pharmacovigilance Agreements© PiCRIS 2014| All rights reserved