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Drug Safety Solutions

Bioclinica is experienced in using all major safety databases on the market today and can help a new or existing client review and select a new system based on changed safety data requirements.

Drug Safety Solutions provide the depth and breadth of Operational support with Physicians and Scientists. Our team includes more than 1,300 staff located in the EU, USA, Japan, China and India supporting over 35 long-term Clients. Our services to these clients span the full range of drug safety and pharmacovigilance services and also include advisory support on best practices in the management, sourcing and systems deployed in the safety arena. Our support is across five distinct pillars:

Pharmacovigilance

Bioclinica DSS has deep expertise and experience from early phase studies to marketed products. Bioclinica is a safe pair of hands to support clients in both current state whilst planning for your strategic objectives. Our PV SMEs, comprised of both Physicians and Scientists are end-to-end partners for our clients, proactively advising and collaborating in designing and maintaining PV services and systems which are fit-for-future.

  • Approximately 900 of our employees have case processing experience and have processed over one million cases in the last twelve months. 
  • We have over 150 Physicians within the service line to support in both clinical and post-marketing activities.
  • Over 100 Physicians and Scientists form a part of our Aggregate report writing group and have contributed to writing over 500 reports in the last 12 months (including Risk Management Plans (RMPs) and development RMPs).
  • Over 50 Physicians and scientists support in both qualitative and quantitative signal management activities supporting the generation of 8,000 workups and reports in the last twelve months.
  • Over 500 employees are proficient in literature screening activities with a monthly average of 80,000 citations being reviewed.
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Additional Features

  • End-to-end case processing which includes:
    • Intake
    • Triage
    • Medical Triage
    • Data Entry
    • Quality Review
    • Medical Review
    • Approval
    • Submission
    • Reconciliation internally and externally with third parties
  • Literature Management
    • Local Literature screening
    • Global Literature Screening
  • EU QPPV services
  • PV Training
  • PV Quality Assurance services, e.g. CAPA management
  • Audit and Inspection readiness including conducting internal and external audits
  • Aggregate Report writing: 
    • Including PSURs, PBRERs, DSURs. AdCos, PADERs
    • Expedited Reporting
    • Submission 
  • Signal Management
  • Risk Management Plan (RMP) and REMS writing 
  • Language Capability
    • Translation capability for 170+ languages across the globe delivered by our strategic partner
    • In-house language capabilities for Portuguese, Spanish, French, German, Italian and Japanese

Over 1 million cases processed in the last 12 months.

Over 900 aggregate reports generated in the last 12 months.

960,000+ citations reviewed regularly.

Over 8000 reports processed annually for signal detection.

Medical Information

Our Medical Information (MI) subject matter experts SMEs, comprised of Physicians, translators, Healthcare Professional (HCPs) and Scientists are end-to-end partners for our clients, proactively advising and collaborating in designing and maintaining services and systems which are fit-for-future.

Our team has processed over 30,000 calls in the last twelve months. Clients are supported in an agile manner to support call volumes in a compliant manner.  We support our clients in over 52 countries worldwide.  The intake of such a high volume of calls has resulted in Bioclinica proactively supporting our clients significantly in the Medical Information space including:

  • Customer intake
  • Customer Follow-up
  • Medical Information
  • Prepaid mailers
  • Closure letters
  • Call transfers
  • Management and tracking of calls
  • Translations
K+
Calls
received in the last 12 months
+
Countries
Supported
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%
Safety
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Regulatory Affairs

Providing assistance throughout the development, approval and post-approval stages of a product’s lifecycle.

Our team have extensive experience in helping companies achieve the necessary preparation and compliance as required by the FDA, EMEA and other global regulatory bodies. Our solutions are customized to suit each client; ranging from supplementary support to a client’s existing team through to a complete outsourced regulatory affairs function. 

  • Regulatory Consulting Support
  • Regulatory Medical and Technical writing
  • eCTD Services
  • Strategic labelling
  • Regulatory Global submission – ensuring compliance to regulatory bodies
  • Bioclinica also have an in-house tool, RITRACE, a Regulatory Information Management portal, which provides a consolidated database of all Regulatory Intelligence information.

Research In Pharmacy And Health Sciences

Advisory

  • Affiliate management
  • Business planning and investment (e.g. due diligence)
  • Patient Centricity in Drug Safety
  • Sourcing strategy
  • Assessing and designing structures, resources and capabilities
  • Drug Safety Road Map
  • PV Benchmarking

Technology Enablement

A key pillar of our delivery services is the use of proprietary technology enablers to improve workflow, efficiency and quality. Our IT team support us in the continuous evolution and enhancement of our TRACE products which we design for our clients with our clients. The need to introduce IT within PV became a necessity as the demand for our clients grew extensively. Through this development we leverage our bespoke TRACE products to support in real-time vendor oversight, performance management, KPI oversight, CAPA management, along with literature, aggregate report and signal management tracking, in line with clients’ corporate requirements.

  • Trace Products 
    • PVTrace
    • ASRTrace
    • LitTrace
    • SigTrace
    • RITrace
  • RPA embedded services
  • Client collaborations on RPA initiatives
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For post-marketing drug safety surveillance, Bioclinica provides:

  • End to end pharmacovigilance services including receipt, processing and scientific analysis, submission, and distribution of Individual Case Safety Reports (ICSRs)
  • Global and local literature management
  • Aggregate report generation, submission, and distribution
  • Signal management
  • Risk Management Plan (RMP) and Risk Evaluation and Mitigation Strategy (REMS) generation
  • Preparation and maintenance of Pharmacovigilance System Master File (PSMF)
  • Local and EU QPPV services
  • Medical Information Contact Center (MICC) services and language capabilities
  • PV quality assurance
  • Local affiliate management
  • TRACE products

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