Pi-CRIS (Latin-America)

logo_picrisPi-CRIS Consulting has worked in the Latin America region from Mexico to the tip of Argentina for more than 13 years.   While our primary focuses are Argentina, Brazil, Chile, Peru, and Mexico, we are a network of professionals throughout Central and South America capable of providing critical support for your projects.  Our Latin American emphasis gives us the ability to instantaneously provide the necessary support for clients regardless of location.  Because we believe that people are our most important asset, we have built a “dream team” to help you resolve your key regulatory, quality, and pharmacovigilance questions.

We offer a wide range of GCP clinical research related activities, including auditing, regulatory, training, and pharmacovigilance service to CROs, pharmaceutical, and biotechnological companies, clinical trial investigational sites and academic institutions. Our business is geared towards supporting all aspects of clinical research and we can also support your project from its inception to its completion.  While not a full-service CRO, we have an extensive network of professionals who can help you identify clinical sites through our site finders service; identify and qualify Independent Ethics Committees, and monitor and audit all aspects of ongoing clinical trials to confirm adherence to GCPs and the Clinical Protocols.  We are also skilled GMP providers who can support the production and supply of drug products from the United States, Europe, India, and China for clinical trials to be conducted within the region.  Coupled with our ability to support your European trials, we offer Qualified Person services to allow you to manufacture your Investigational Medicinal Drug Products in Latin America.    As an unbiased third-party we are able to objectively evaluate your activities and provide corrective actions, if needed, in both GCP and GMP activities.

Our Regulatory services allow “one-stop-shopping” for all your Latin American clinical trial submissions.  We have extensive capabilities to allow you to get to the clinic as soon as possible and can fully support your projects beyond the submission stage. 

Our company can also satisfy the needs of the pharmaceutical authorities by providing comprehensive Pharmacovigilance (PVG) services and risk management solutions for marketed medicinal products in the challenging regulatory framework in Latin America.

OUR SERVICES

Clinical Trial Set-up

  • Production of Standard Operating Systems
  • Investigational site review, initiation, and auditing
  • Trial Master File auditing
  • Patient record monitoring
  • Investigational Medicinal Product Supply and Distribution within each Latin American country

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

CONTACT US:

Pi-CRIS Consulting Group
Paula Valeria Casasco
20900 NE 30th Avenue, Suite #200
Aventura Florida, USA  33180
+1(305)960-1126