At PiVOT, we understand that Pharmacovigilance is an important part of the drug development process, and we are dedicated to providing end-to-end project management to support your PV efforts. We are committed to helping you ensure that your PV program meets the highest standards of safety and effectiveness. With our comprehensive set of services, we can help you monitor and assess the safety, effectiveness, and use of drugs, and provide regular reports on any potential risks or adverse events.
At PiVOT, we understand the importance of Regulatory Affairs in the conduct of Clinical Trials. As professionals that serve as an interface between the regulatory authority and the project team, we are also the channel of communication within the regulatory authority as the project proceeds, aiming that the project plan correctly anticipates what the regulatory authority will require before approving the clinical trial.
At PiVOT, we understand that the success of a clinical trial depends on the accuracy and integrity of the data. Our team of experienced professionals will work with you to ensure that all data and documentation related to the trial is managed efficiently, securely and accurately.
PHARMACOVIGILANCE
REGULATORY AFFAIRS
DATA MANAGEMENT
Medicinal Device
Including Technical Complaints
Cosmetics
Cosmetovigilance
Medicinal Products
Drugs, Vaccines
Medicinal Device
Traditional & Alternative Medicine
Case Intake
Case Receiving and Triaging
Case Processing
Includes Data Entry, Coding - MedDra®, Causality, and Expectedness Assessment, Narrative Writing, and Internal Quality Check.
Medical & Scientific Review
Medical Review of Physician
Regulatory Submissions
Electronic and Manual
Regulatory Affairs is the vital connection between your company, its products and the Regulatory Authorities. We combine our expertise in science, law, and business to ensure that products developed, manufactured, and distributed by various companies meet the requirements of legislation and levels of quality, safety, and efficacy that are expected.
Drugs & Medical Devices
Strategic Planning
Regulatory Agency Interactions
Regulatory Preparation & Submission
Technical and Scientific Writing
Regulatory Compliance
Regulatory Intelligence
Regulatory Intelligence is the monitoring, gathering, and analyzing of publicly available and experience-based regulatory information to develop a strategy for time- and cost-efficient drug development, clinical trial start-up, and product registration to the National Regulatory Authorities.
Monitor the landscape
Analyze the information
Form a Strategy
DMP, CRF Design, EDC Set-up, Edit Check Setup, UAT / Training
Discrepancy Management Data Coding Query Management Medical Review SAE Reconciliation
DMR Preparation Data Review Meeting Database Lock Database Transfer Archival
Final Study Report
CRScube's Solutions have been deployed and used in more than 4,000 trials across therapeutic areas and Phases globally.
Study Setup
Data Collection
Randomization & IP Management
Risk-based Monitoring
Robust Reporting
Pharma covigilance
Learning Management System
