Clinical Trial Support Services (CTSS)

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.




End to End Pharmacovigilance (PV) Services for:

  • Marketed Pharmaceutical Products (Post Regulatory Authorization/Approval)
  • Investigational Medicinal Products (IMPs) and Medical Devices.


  •  Combined Number of Cases Processed by the PV Team


  • 24/7 Central Pharmacovigilance Reporting System (CPRS)
  • One Stop Shop for PV Reporting Philippines’ FIRST Electronic PV System

Clinical Trials (Solicited) and Phase IV/Post-Marketing (Solicited and Unsolicited/Spontaneous reporting activties) Operations Support

Medicinal Device

Including Technical Complaints



Medicinal Products

Drugs, Vaccines

Medicinal Device

Traditional & Alternative Medicine

Pharmacovigilance Workflow

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.

Three important steps for Regulatory Intelligence to work:

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

Partner with

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