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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.

Handy guide for the pharmacovigilance folks! https://t.co/tOyQWkiNhW
bioclinica (Yesterday)
#ClinicalResearch sites, REJOICE @bioclinica SMART Submit 4 cloud rsch image mgmt /subm is here! @OutsourcPharmahttp://ow.ly/odCh30grhnY
bioclinica (Yesterday)
What's next from Bioclinica? Hear if first during #PCTrials Europe next week in Amsterdam! https://t.co/ICngaxA9mg https://t.co/SXxPj3NpD2
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Join Bioclinica's Justin Hunt on Nov. 28 in a live webinar! Find out how to overcome common hurdles in CTMS impleme… https://t.co/wHfWHtI7sj
bioclinica (3 days ago)
Another CRO seeing big gains in the sites payments process! Access the Case Study here https://t.co/jsCxhmKcLo https://t.co/LpIKEtBKtE
bioclinica (3 days ago)
Great advice from our Dir. Cardiovascular Imaging on quality imaging acquisitions & assessments in clin trials. https://t.co/OVH7pZ3SL0
bioclinica (3 days ago)

Latest Blogs:

Removing Risk from Clinical Trial Management System (CTMS) Implementations
Collaboration Between Clinical Operations and the Logistics and Supply Chain Teams is Key to Trial Success
The Value of Protocol Review
CTMS and RBM: Hot Topics at OCT Nordics in Copenhagen
Congressman Meehan and Bioclinica CEO John Hubbard at recent visit to Bioclinica's Audubon offices