Data Management 

Our team offers an end-to-end solution for clinical data management from CRF development, database build and design, to supporting Data Safety Monitoring Board (DSMB) and Data Management Committees (DMC) meetings. The InClin team has experience with a variety of EDC platforms; we work with each sponsor to find the best-fit-solution for their needs.

Our data management colleagues are located in several time zones across the US and AUS, ensuring appropriate coverage for our sponsor studies.

InClin Clinical Data Management Services

• CRF development
• Develop Edit Checks
• Database design and build in multiple EDC platforms
• Integrating IWRS with EDC as needed
• Database User Requirement Testing
• Data Management and Quality plan development
• Adverse Events and medication coding
• Serious adverse event reconciliation
• Query management
• Manual listing review for data quality
• Database freeze and lock
• Support Data Safety Monitoring Boards (DSMB), Interim and Data Monitoring Committee (DMC) meetings
  • Charter development
  • Meeting report (including interim efficacy analyses) preparation
  • Data presentation
  • Member participation

InClin’s Data Management team has supported 140+ studies as a part of full-service and standalone Biometrics opportunities. Our team is highly experienced and has the flexibility to seamlessly integrate with InClin’s internal project teams, and Sponsor teams.

Biometrics

Our Biometrics Department is comprised of three key teams: Clinical Data Management, Biostatistics and Statistical Programming. Collectively, they provide an integrated and comprehensive approach to clinical data capture, analysis and presentation.

Our team is able to support both full-service and standalone opportunities, as well as, Biometrics consulting. 

The InClin Advantage – What sets us apart?

• Technical Expertise — Trained professionals skilled at analyzing, synthesizing, and presenting data, allowing the client to focus on strategic review
• Comprehensive Experience — Our broad industry knowledge allows us to tailor our services to achieve each Sponsor’s specific goals
• Tailored Solutions — We work with a wide range of companies, from regional to global corporations, who have diverse products and development needs
• Proven Quality Processes — We use validated templates and quality reviews to produce high-quality deliverables that adhere to regulatory style guidelines
• Collaborative Environment — We work as an integral part of your team with the belief that we can achieve more together
• Resource Rich — We are flexible and can add resources to your team, as needed, to ensure that timelines are met, even as your project evolves

Additional Services

Regulatory Support

In addition, our Biometrics team collaborates seamlessly with regulatory and medical writing to provide the following services: 

• Strategic direction recommendations
• Briefing package preparation
• Regulatory agency meeting statistical discussion and presentation
• Regulatory submission-ready data, programming and analysis package
• Integrated summaries of safety and efficacy
• CSR statistical authorship
• New drug/device application and other report (eg, annual safety/IND reports) review and editing

Pharmacokinetics and Pharmacodynamics

InClin also works with a partner to support pharmacokinetics and pharmacodynamics analyses including:

• Non-compartmental analysis and reports using Phoenix WinNonLin
• Biomarker evaluation and analyses
• Relational analyses of the PKPD parameters to primary endpoints