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Global Pharmacovigilance Consulting
for Life Science Organizations

Patient and trial subject safety is at the heart of every life science firm’s mission. Pharmacovigilance consulting can help ensure drug safety and regulatory compliance so you keep your patients safe, avoid fines and keep drugs on the shelves. Our team has helped some of the world’s most innovative pharmaceutical, biotech and medical device companies overcome complex pharmacovigilance challenges, and we’re ready to meet your needs.

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Results-Focused
Pharmacovigilance Services

Properly functioning, compliant pharmacovigilance (PV) systems are critical to the performance of pre- and post-marketing drug safety efforts. With the right solutions and workflows in place, PV teams are at their most efficient and effective.

Our team has extensive experience helping life science firms of all sizes select, implement, integrate, migrate, audit and tune pharmacovigilance platforms. We combine realistic, sustainable strategies with highly adept execution to deliver real-world results and lasting business impact. Your success is our success.

Migrate to a New PV System with Ease

Modern PV systems are highly complex, with complicated data models that are difficult to interpret, which can lead to challenges with understanding if you are under- or over-reporting adverse events. To compound these problems, many companies need help managing hundreds of thousands of cases annually that require expert review.

Daelight offers support to navigate these complexities, ensuring adherence to SOPs, identifying anomalies in data and facilitating transitions to simpler systems like Vault Safety. Our PV migration services include:

  • Strategy
  • Assessment and planning
  • Gap analysis
  • Data migration
  • System configuration updates
  • Training
  • Validation

Simplify Migrations with the DMT

In addition to consulting, we create innovative solutions like the Daelight Migration Tool (DMT) to streamline the migration experience for PV systems.

DMT ensures the safe transfer of data and content from legacy platforms to Veeva Vault. It also follows industry best practices to address intricate migration requirements in a cost-effective manner.

EXPLORE DMT

Streamline Data Extraction & Analysis with DVQT

The Daelight Vault Query Tool (DVQT) enables power users to pull and examine data from Veeva Vault instances. Featuring a dynamic graphical interface, DVQT streamlines data extraction to enhance speed and efficiency. Use DVQT to execute VQL seamlessly and retrieve extensive data sets without the concern of hitting API call limits.

EXPLORE DVQT

Get a Pharmacovigilance Health Check

Partnering with Daelight for a comprehensive health check can provide invaluable assurance and peace of mind. Our team specializes in PV infrastructure assessments to ensure your system has been maintained properly, SOPs are being followed, training is sufficient, etc.

We meticulously double-check the data, ranging from case reports to adverse event information, documents, and configuration data (product, license, study, reporting rules, etc.) to ensure there are no anomalies or broken data points. This thorough examination helps identify any discrepancies or issues that may have arisen over time, allowing us to address and rectify them promptly.

ASK ABOUT THE HEALTH CHECK

Effective PV System Configurations

When your PV team finds it challenging to keep up with the intricate system configurations required, Daelight steps in as your trusted partner to take charge. By ensuring your configurations are up-to-date, we enable your team to respond swiftly and effectively to adverse events as they arise.

Our expertise lies in maintaining all types of PV configurations, including:

  • Product, Study, License and Reporting Rules (PSLR)
  • Gateway connections
  • E2B R2/R3 customizations/configurations

Experts in Drug Safety Software

Daelight’s consultants have hands-on experience in all leading PV software systems, including:

As a Veeva Preferred Services Partner and Certified Migration Partner, we have successfully completed complex GxP-validated migrations and integrations for clients like you. When you need a reliable partner to move your data to Vault Safety, trust us to deliver.

We’ve helped customers like you with various tasks, including:

  • 500,000 documents migrated from a Legacy Documentum (FirstDoc)
    system to Vault eTMF
  • Study startup data migrated from goBalto and Trial Master File (TMF)
    documentation to Vault SSU and eTMF
  • Over 1 million objects migrated from Siebel CTMS to Vault CTMS
  • Documents and training items migrated from legacy systems (MasterControl
    and Montrium QMS) to Vault QualtyDocs and Training
  • Over 2+ million cases and 11 million documents migrated from Oracle Argus
    to Vault Safety

Whatever the technology stack, our pharmacovigilance consultants bring unique expertise and methodologies to help you:

  • Select and implement the right PV system for your needs
  • Develop and streamline adverse event reporting intake, workflows
    and case management
  • Support highly scalable, end-to-end safety processes
  • Ensure compliance with all relevant regulations and guidelines,
    including 21 CFR Part 11
  • Audit cloud-based or on-premise systems for compliance and best practices
  • Integrate PV solutions with complementary systems, like Registration
    Management and CTMS platforms

Case Study: How Daelight Assessed a Client’s Argus System to Reduce Risk

A mid-size pharma and medical device company using Oracle Argus to track and report adverse events partnered with Daelight to take a deep dive into the systems’ configurations, processes and procedures to ensure everything was up-to-date. Daelight successfully delivered the following deliverables:

  • An executive summary highlighting each risk and issue, followed by
    Daelight’s recommended next steps
  • Detailed recommendations for configuration updates
  • Actionable insights so the client could decide what to fix and when

Check out our full case study to learn how we made this all possible.

READ CASE STUDY

Talk with a
Pharmacovigilance Expert

Daelight offers comprehensive support for all your pharmacovigilance needs, from strategic planning to flawless execution. We understand business processes and are well-versed in data management and the latest technologies crucial for effective pharmacovigilance operations. Plus, our extensive partner network enables us to expand our capabilities and scale up as needed, ensuring that we can tackle projects of any size or complexity with confidence and efficiency. Whether you require strategic guidance, technological solutions or project execution, Daelight is your trusted partner
every step of the way.

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Frequently Asked Questions

Pharmacovigilance, also known as drug safety, is the science and activities related to detecting, assessing, understanding and preventing adverse effects or any other drug-related problems. It involves monitoring the safety of potential candidates and the pharmaceutical products used in clinical studies. Drug safety continues after pharmaceutical products have been released on the market, ensuring that any adverse events or side effects are identified and evaluated. Pharmacovigilance aims to enhance patient safety and ensure that the benefits of a drug outweigh its risks by continuously assessing and managing the safety profile of medicines.

Veeva Vault Safety is a cloud-based pharmacovigilance and drug safety management solution provided by Veeva Systems. It’s designed to streamline the capture, management and reporting of adverse events and safety data. Veeva Vault Safety enables life sciences organizations to comply with global regulatory requirements, improve the efficiency of safety operations and ensure patient safety.

Product, Study, License and Reporting Rules (PSLR) is a framework used within pharmacovigilance and regulatory information management to organize and manage the various regulatory requirements and reporting obligations associated with a medicinal product. By systematically managing PSLR information, organizations can ensure compliance with regulatory requirements and enhance the efficiency and accuracy of their pharmacovigilance activities.