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Scientific Services

What we do

Our Scientific Services team can provide experienced subject matter experts to support your required day-to-day activities in Clinical, Medical Affairs, Regulatory, Quality, and Safety. From foundational support to more cutting-edge strategic services, our team of experts serves as a trusted specialized partner for our life science clients.

Images of a smiling woman at a kitchen table engaging with an HCP. From the iTC app. Images of a smiling woman at a kitchen table engaging with an HCP. From the iTC app.

Clinical Research & Medical Affairs

Clinical

  • Video & Telemedicine Assessments
  • Video Clinical Outcome Assessments (vCOA)
  • Video patient reported outcomes (vPRO)
  • Clinical Study Management
  • Data Management
  • Electronic Data Capture
  • Medical Writing
  • eTMF and CTMS Operations
  • CRO Partnerships
  • Clinical Information Management

Medical Affairs

  • Patient Registries and Long Term F/U
  • Real World Evidence Strategies

iTakeControl

A comprehensive mobile platform for decentralized research trials, evidence-based research, and learning programs

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Regulatory

  • Regulatory Strategy
  • Labeling
  • Regulatory Information Management
  • Submission Management and Publishing
Image of various icons surround a red globe, including HCPs, patients, and regulatory personnel, from the DirectusPRO video. Image of various icons surround a red globe, including HCPs, patients, and regulatory personnel, from the DirectusPRO video.

REGULATORY PRODUCTS & RESOURCES

DirectusPRO logo

DirectusPRO

Our unique, comprehensive global label management, tracking, and reporting solution.

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ILAC logo

ILAC

The Industry Labeling Advisory Committee resource center brings together labeling industry leaders.

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Partner Vault logo

Partner Vault

Our efficient and cost-effective Regulatory Information Management (RIM) solution.

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A series of pharma flasks with periwinkle liquids; one is missing a cap. A series of pharma flasks with periwinkle liquids; one is missing a cap.

Quality

  • Controlled Document (including SOP), Strategy, Management and Deployment
  • Inspection Readiness
  • Audits
  • Change Management
  • Vendor Management
  • Complaints and Investigations
  • Validation and Qualifications

Safety

  • Adverse Event Management
  • Medical Monitoring
  • Safety Operations
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