Data Research and Support Services for Drug Safety and Pharmacovigilance
Published on: 27 Oct 2025
Last updated: 27 Oct 2025
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As drug development becomes more complex and the patient population more diverse, the field of drug safety faces dynamic and evolving research needs. These needs span the entire drug lifecycle, from pre-clinical studies to expansive post-marketing surveillance, all focused on continuously improving patient safety.
A primary focus area for pharmacovigilance research lies in addressing data and analysis needs to effectively manage the sheer volume and complexity of safety information. We need comprehensive data collection across all stages, including spontaneous reports, literature, and observational studies.
Crucially, this requires the integration of advanced analytical tools, such as data mining and Artificial Intelligence (AI), to process these vast datasets. The ultimate goal is a more robust signal detection capability—the ability to promptly and accurately flag potential new or emerging adverse events for further investigation.
Finally, research must also prioritise the proactive management and evaluation of risks. There is a pressing need for better Risk Management Plans in the post-marketing setting to mitigate identified risks effectively. Furthermore, collecting Real-World Evidence (RWE) through studies like post-authorisation safety studies is essential to understand drug safety profiles in diverse, uncontrolled populations—the true reality of medicine use.
Serving these specialised and multifaceted pharmacovigilance and drug safety research needs requires a strategic and flexible approach. This is where custom research solutions become indispensable. Unlike standardised research frameworks, custom-designed studies can precisely target specific data gaps, leverage unique analytical methodologies, and incorporate the necessary level of collaboration to address a particular safety concern, thus offering the most effective pathway to enhanced drug safety throughout the lifecycle.
Data Partners who specialise in bespoke data research and support services for drug safety and pharmacovigilance, uniquely combine human expertise with advanced software automation to deliver unparalleled data quality.
Such a tailored approach to data collection makes data partners the ideal choice for pharmaceutical companies, CROs (Contract Research Organizations), and life sciences research organisations seeking trustworthy, regulatory-compliant data solutions.
Understanding Drug Safety and Pharmacovigilance Data Needs
Pharmacovigilance refers to the science and activities relating to the detection, assessment, understanding, and prevention of adverse effects or any other drug-related problems. Capturing high-quality data on drug safety is essential for identifying risks, supporting regulatory submissions, and ensuring effective post-market surveillance.
Key data types required include:
Adverse event reports
Clinical trial safety data
Post-marketing surveillance data
Literature and case report data
Regulatory compliance documentation
Data research in this domain is complex due to stringent regulatory standards such as those from the FDA, EMA, and ICH guidelines. Data freshness, completeness, and accuracy directly impact patient safety, regulatory approval, and real-world drug efficacy monitoring.
Why Bespoke Data Research is Vital for Pharmacovigilance
Many providers offer data by scraping publicly available databases. These approaches often result in incomplete or outdated datasets that risk non-compliance or inaccurate safety signals.
Ascentrik Research’s bespoke data research model, developed through years of specialised experience in life sciences, combines full-time expert human researchers with robust automation. This hybrid method delivers:
Superior data accuracy: Human researchers validate and enrich data sources, ensuring critical context and removing noise.
Never scraped data: Proprietary processes prevent raw scraping of online databases, mitigating errors and copyright issues.
Up-to-date insights: Continuous manual curation alongside automated tools ensures the freshest data to match fast-moving regulatory requirements.
Data uniqueness: Tailored queries and human curation produce insights unavailable in pre-packaged datasets.
This approach enhances data reliability for pharmacovigilance teams, enabling better risk management and faster regulatory decision-making.
The Ascentrik Research Advantage: Human Expertise Meets Automation
Our full-time team of data experts includes pharmacovigilance specialists, medical researchers, and data analysts who conduct rigorous primary research rather than relying solely on secondary or scraped data. We employ a multi-step process that includes:
Custom data sourcing: We identify and extract data from validated, authoritative sources carefully filtered by subject matter experts.
Manual verification: Every data point undergoes human validation, ensuring accuracy and relevance.
Software-driven enrichment: With proprietary automation tools, our team augments data to add structured metadata and cross-reference multiple datasets.
Regulatory compliance review: Our data aligns with the latest global regulatory standards, and local health authority requirements.
Ongoing updates: Continuous research cycles ensure databases remain current, supporting real-time pharmacovigilance needs.
The synergy between expert human intervention and automation makes Ascentrik’s data solutions uniquely qualified to support complex drug safety operations.
Applications in Life Sciences and Healthcare Research
Ascentrik Research serves a wide range of clients in the pharmaceutical and healthcare sectors, including:
Pharmaceutical manufacturers who need accurate adverse event data for safety signal detection and risk minimisation.
Clinical research organizations (CROs) conducting pharmacovigilance studies requiring fresh, validated datasets for regulatory submissions.
Healthcare providers and academic institutions performing post-market surveillance and pharmacoepidemiological research.
Regulatory consultants needing compliance-ready data to address health authority queries and inspections.
Our bespoke data research helps organisations improve patient safety monitoring, reduce regulatory risks, and accelerate drug development lifecycle decisions.
Enhancing Regulatory Compliance with High-Quality Data
Compliance with pharmacovigilance regulations is non-negotiable. Incomplete or erroneous data submissions can result in regulatory sanctions, recalls, or delayed approvals. Ascentrik’s data research services support compliance by ensuring datasets are:
Complete and documented: Capturing all required data points with detailed provenance and audit trails.
Fresh and timely: Reflecting the latest safety signals and adverse event reports.
Regulation-aligned: Designed to meet the data requirements of global bodies including FDA REMS, EMA PRAC, and WHO PIC/S.
Accurate and consistent: Validated to reduce false signals and improve signal detection sensitivity.
This compliance focus reduces risk while supporting transparent and efficient regulatory review processes.
Ensuring Data Freshness and Uniqueness in a Competitive Market
Pharmacovigilance is a fast-paced field where new safety issues can arise within days of drug release. Traditional data sourcing approaches often lag behind real-time developments, limiting responsiveness.
Ascentrik Research’s continuous data update methodology and human-driven verification mean data is consistently refreshed to capture the most current safety events and regulatory changes. Our datasets provide unique insights not found in off-the-shelf or scraped sources, giving clients a competitive advantage:
Early detection of emerging safety signals
Improved accuracy in benefit-risk assessments
Customised data aligned with client-specific therapeutic areas
This freshness and uniqueness enable pharmacovigilance teams to act quickly and decisively, improving patient outcomes and regulatory standing.
How Ascentrik Research Supports Data Accuracy and Quality
Our quality assurance protocols include:
Multi-layer validation: Cross-checking data across multiple authoritative sources.
Human review cycles: Pharmacovigilance experts manually audit datasets to maintain precision.
Automated quality controls: Software detects anomalies, duplicates, or missing fields.
Feedback loops: Client input is integrated to continuously enhance data relevance and accuracy.
This stringent quality framework ensures that pharmacovigilance data delivered by Ascentrik Research meets the highest industry standards for accuracy and integrity.
Partnering with Ascentrik Research for Your Pharmacovigilance Data Needs
Choosing the right data research partner is critical. Ascentrik Research offers:
An experienced and dedicated team focused exclusively on life sciences data research.
A custom, non-scraping approach combining human expertise with automation.
Commitment to regulatory compliance, data accuracy, freshness, and uniqueness.
Flexible service models to integrate into your pharmacovigilance processes seamlessly.
Confidentiality and privacy-focused research practices.
Our solutions empower pharmaceutical and healthcare organisations to make informed, data-driven decisions that protect patient safety and meet regulatory challenges head-on.
Conclusion: Elevate Your Drug Safety Data with Ascentrik Research
In the dynamic world of drug safety and pharmacovigilance, relying on generic, scraped datasets can compromise compliance and patient safety. Ascentrik Research’s bespoke data research and support services, driven by full-time experts and innovative automation, offer life science organisations a superior choice. Our unparalleled data accuracy, freshness, and regulatory alignment enable your pharmacovigilance teams to excel in safety monitoring, risk mitigation, and regulatory reporting.
Partner with Ascentrik Research to access truly actionable pharmacovigilance data that makes a measurable difference — safeguarding both patients and your organisation’s reputation.
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