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Safety & Regulatory Solutions

Bioclinica Safety & Regulatory Solutions offers specialized drug safety, regulatory affairs and clinical services across all therapeutic areas. Partner with the #1 pharmacovigilance services provider in the industry.

Safety and Regulatory

A Passion for Drug Safety

At Bioclinica we believe in process excellence and an unwavering commitment to quality. We deliver on this promise through our domain expertise and industry-unique Engagement Management model:

  • Local (on-site or nearby) engagement managers with minimum 5+ years PV operations experience, lead all customer engagements
  • Bioclinica engagement managers coordinate activities with the delivery teams to ensure a smooth experience and provide you with a single point of contact in your time zone
  • High-quality PV, regulatory and QPPV services from experienced safety and regulatory professionals:
    • All 1000 operations employees worldwide are Healthcare Professionals (HCPs)
    • Delivery teams are fully dedicated to each client with each team having a “buffer” to account for scalability
    • Industry-leading personnel retention in delivery center locations
  • Proven ability to process high case volumes and manage volume fluctuations
  • Rigorous quality standards supported by daily metrics
  • System-agnostic Pharmacovigilance-as-a-Service (PVaaS), cloud hosting and Argus/ARIS excellence

Passion Drug Safety

Leverage Bioclinica's Expertise

Partner with the #1 pharmacovigilance services provider in the industry.

CONTACT US DOWNLOAD BROCHURE

Your Global Partner for Complete PV Services

DRUG SAFETY

  • ICSR - Case Processing (500K cases annually)
  • Safety Call Center
  • ICSR Submissions
  • Literature Surveillance
  • Aggregate Reporting Services
  • Signal Management
  • Risk Management Plans
  • QPPV Services
  • Consultancy

REGULATORY AFFAIRS & CLINICAL

  • Global Submissions
  • Regulatory Medical and Technical Writing
  • eCTD Services
  • Core Labeling Services
  • XEVMPD Services
  • Risk Management (RMP/REMS)
  • Lifecycle Management

IT SERVICES

  • PV-as-a-Service (PVaaS)
  • PV Automations
  • Application and Infrastructure Management
  • Business Intelligence and Reporting
  • Business and Technical Consulting
  • IT Validation
  • Argus/ArgusJ and ARIS/ARISj Implementations, as well as other safety systems (standard and Japanese)

Enabling Greater Customer Business Value

Process Excellence / Optimization

Absolute Commitment to Quality

Exceeding Industry Standards

Innovation in Technology

Pharmacovigilance by the Numbers

99
Case Submission Compliance
98
Turnaround Time for All Cases
96
Quality Across All Projects
98
Literature Assessment Accuracy
3
Safety Call Center Call Abandon Rate
12
Onboarding Time for New Clients

PV-as-a-Service (PVaaS) is an end-to-end service model where Bioclinica provides PV services to the client and manages the underlying applications and infrastructure. The Bioclinica PV-as-a-Service includes:

  •   Infrastructure and Application Hosting

  •   System Implementation

  •   Application and Infrastructure Support

  •   Case Processing

  •   Aggregate Reporting

  •   Literature Review

THOUGHT LEADERSHIP

Leverage Bioclinica's Expertise

Are you ready for eCTD submissions?

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THOUGHT LEADERSHIP

THOUGHT LEADERSHIP

  • 1000+ PV and Regulatory Experts
  • Industry Leading PV Solutions
  • Frequent Presenter at Industry Events

PROCESS OPTIMIZATION

  • Efficiency gains of 40% - 60%
  • Workflow Optimization
  • PV Automations

PV-AS-A-SERVICE (PVAAS)

  • Full Suite of Services
  • Flexible, Scalable and Secure
  • Rapid Enablement
  • Argus/ARIS Experts

COMPLIANCE

  • EMA, FDA, PMDA
  • Regulatory Services
  • QPPV and Audit Support
  • HIPAA and CFR Part 11 Compliant

DRUG SAFETY SERVICES

Providing drug safety and pharmacovigilance services to small, mid- and large-sized pharmaceutical and biotechnology companies.
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DRUG SAFETY TECHNOLOGY

Our technology tools aim to address our clients' pain points and act as process accelerators, providing a validated, one-stop shop solution for clients.
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REGULATORY AFFAIRS

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

Experts in the development, support and maintenance of IT infrastructure and applications within life science organizations.
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Leader in Clinical Trial
Management Solutions

Bioclinica is organized into three business segments so that we can provide expert service and multifaceted technologies. Our Medical Imaging & Biomarkers segment includes an Imaging Core Lab, a Cardiovascular Safety division, and a Molecular Marker Laboratory. Our eHealth segment comprises eClinical Solutions, Randomization & Trial Supply Management, Safety & Regulatory Solutions, and Financial Lifecycle Solutions. Under the Global Clinical Research segment, we offer a network of research sites, patient recruitment, and a Post-Approval Research division.

RT @bioclinica: Attending CBI's IRT conf? Catch 10/27 @bioclinica GSK talk on bens of sponsor controlled #IRT. Here's the core tech https:…
bioclinica (3 days ago)
RT @Xtalks: Clinical Event Adjudication: Comprehensive and Efficient Dossier Review Using a Global On-Line Solution @bioclinica https://t.c…
bioclinica (3 days ago)
RT @eClinical_Jen: Good Morning from NJ! @bioclinica is a sponsor of the clinical supply show because we have awesome supply forcasting and…
bioclinica (4 days ago)
Attending CBI's IRT conf? Catch 10/27 @bioclinica GSK talk on bens of sponsor controlled #IRT. Here's the core tech… https://t.co/zFiQswIQFb
bioclinica (5 days ago)
RT @Xtalks: #Cardiovascular Imaging for Monitoring Safety: Visualizing Outcomes @bioclinica https://t.co/5osqBkDFKm
bioclinica (5 days ago)
Want stellar imaging acquisition & assessment in your #clinicaltrial ? Get tips in @bioclinica 's Tim Crowe's blog https://t.co/hzbV3Cmlyc
bioclinica (6 days ago)

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