Full-Lifecycle Trial Support, Tailored to Your Needs
Expert support in pharmacovigilance, regulatory affairs and data management
PiVOT offers targeted functional services to support trial success at every stage. From regulatory readiness to patient safety oversight, our teams deliver high-quality execution aligned with international standards.
Pharmacovigilance (PV)
Our PV team supports safety reporting across the product lifecycle—ensuring accurate, timely, and compliant safety data management.
KEY SERVICES:
Safety monitoring and reporting
Management of both solicited and unsolicited adverse events, with timely submission to authorities and stakeholders.
Case processing, regulatory submissions
Safety oversight for Phase IV trials, Post-Marketing Surveillance (PMS), Real-World Evidence (RWE) studies, and special product categories including cosmetics and traditional medicine.
PV for Post-Approval Studies
Ensuring efficient case intake, medical review, and timely submission to regulatory authorities.
Regulatory Affairs
We navigate complex regulatory landscapes to help you bring your product to market—efficiently and compliantly.
SERVICES INCLUDE:
Strategic planning and regulatory pathway development
Tailored roadmaps that define the optimal regulatory pathway based on product type, market, and development phase.
Interactions with national regulatory authorities
Coordination of meetings, scientific advice, and communication with national regulatory authorities (e.g., FDA, EMA, NRAs)
Dossier preparation, submission, and tracking
Compilation, review, and electronic submission of CTDs, variations, and other key regulatory documents, with robust tracking and status updates.
Scientific and technical writing
Preparation of high-quality regulatory documents, including clinical overviews, risk management plans, investigator brochures, and labeling.
Ongoing regulatory compliance management
Ongoing support for variations, renewals, and market-specific compliance activities to ensure long-term product viability.
Regulatory Intelligence
We help you stay ahead of evolving regulations by monitoring and analyzing global and local requirements—then translating insights into actionable strategy.
OUR THREE-STEP APPROACH:
1. Monitor the regulatory landscape
We continuously track local and global regulatory updates to keep your development plans aligned.
2. Analyze and synthesize key information
Analyze and synthesize key information - Our team distills complex changes into actionable insights, identifying risks and opportunities.
3. Develop a clear, cost-effective regulatory strategy
We craft tailored strategies that streamline approvals while ensuring full compliance.
Clinical Data Management
Our SOP-driven data management processes ensure your clinical data is clean, reliable, and submission-ready.
OUR END-TO-END SERVICES INCLUDE:
Setup & Design
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Data Management Plan (DMP) -A comprehensive, trial-specific document outlining data flow, roles, timelines, and quality controls.
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Case Report Form (CRF) Design - Designing of data collection forms are done in close collaboration with clinical and statistical teams to capture all protocol-required data accurately and efficiently
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Database Build and Validation -
We configure and test the clinical trial database (Electronic Data Capture (EDC) system) including the programming of data validation checks (Edit Check Specification). This process culminates with User Acceptance Testing (UAT) to ensure the database is fully compliant and production-ready, while staff receive practical EDC training for consistency.
Data Oversight
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Data Validation and Cleaning - Perform both programmed and manual checks to proactively identify errors, inconsistencies, or missing data, including clinical/medical review to confirm data integrity.
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Discrepancy Management (Query Resolution) - Generate and manage queries directed to study sites to efficiently resolve all data issues.
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Medical Coding -
Assign standardized codes (e.g., using MedDRA, WHO-DD) to adverse events, medications, and medical history terms for uniform classification.
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SAE Reconciliation and Data Cleaning -
Conduct ongoing reconciliation between safety databases and clinical data to ensure consistent and accurate adverse event reporting.
Study Closeout
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Data Management Review (DMR) - Conduct a comprehensive audit to confirm data integrity, protocol compliance, and issue resolution prior to database lock.
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Data Review Meetings and Database Lock - Collaborate with stakeholders to ensure consensus and approval before the final database lock.
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Final Database Transfer, Archival, and Study Reporting -
Deliver submission-ready datasets and archival packages aligned with sponsor requirements and regulatory formats (e.g., CDISC/SDTM).