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Resource Library

Success Stories

  • Maximizing Efficiency in EDC Development Process

    Case Study: EDC Database Development Labor for Replicating Similar Studies > 100% More Efficient in iMedNet compared to Legacy EDC System

    SDC takes pride in providing efficient, innovative and effective solutions for our clients. One way we maximize efficiency in data management is by streamlining the database replication process for similar or repeat studies within a clinical program.

    While we have always passed efficiencies through to our clients historically utilizing our legacy EDC system (a well-known and widely used tool in the industry), we have recognized a significant increase in the efficiencies we can provide in replicating similar studies since transitioning to iMedNet EDC in 2012.

    For this case study, we evaluated two examples of the database build and validation process in which we replicated the original study database to develop a similar study database within the same clinical program. In comparing the historic project data outlined below, we found that the database build and validation process for the 2nd study in Program B, utilizing iMedNet EDC, was over 100% more efficient than the 2nd study in Program A, utilizing our legacy EDC system.

    As the most labor-intensive study startup activity for the data management team, reducing the required resources in the database development process can have a considerable impact in helping to meet the timelines and budgetary goals of your project.

    Key Highlights

    Program A
    • Developed in SDC's legacy EDC system
    Program B
    • Developed in iMedNet EDC
    Labor hours compared
    • Database setup/development
    • Data validation development and edit check programming
    • Internal User Acceptance Testing (UAT)
    • Post-production changes to the database and/or validation
    • The database build and validation process for the 2nd study in Program B, utilizing iMedNet EDC, was over 100% more efficient than the same process for the 2nd study in Program A, utilizing our legacy EDC system.
  • Efficient Closeout of Partnered Study

    Dry Eye Study
    * Business Days

    Key Highlights

    • Phase III, multicenter, randomized study
    • 8 months FPFV - LPLV
    • Over 1,000 subjects with data entered into EDC system
    • 13 sites
    • 45,000+ total eCRFs entered
    • 3 weeks from LPLV to Database Lock
    • 5 weeks from LPLV to Final Analysis
    • Top-line analysis delivered within 3 business days after Database Lock
    • Final analysis delivered within 10 business days after Database Lock
  • Expedited Safety Review Meetings: A Clinical Partner Case Study

    SAD Timeline

    Key Highlights

    • Phase 1 single ascending dose (SAD) study
    • 8 Cohorts with safety review meetings following each Cohort
    • 1 week expedited timeline between dosing of each Cohort: - Friday: Cohort dosed
      - Saturday - Sunday: Data Entry completed at site
      - Monday - Tuesday: SDC prepares listings for safety review
      - Wednesday: SDC provides listings for safety review
      - Thursday: Sponsor reviews listings and determines new dosing level
      - Friday: Next Cohort dosed

  • Efficient Solutions: A Clinical Partner Case Study

    * Approximate

    Key Highlights

    • Phase I, single center, pharmacokinetic, pharmacodynamic, and safety evaluation study
    • PK study with tight timeline requirements**
    • Approximately 19 weeks total from protocol development through final Clinical Study Report (CSR): - Protocol developed and finalized in less than 4 weeks over holiday season (mid-December to early January)
      - Complete EDC database released in just over 4 weeks (just over 2 weeks from receipt of final protocol)
      - FPFV to LPLV in just over 3 weeks
      - LPLV to Database Lock in just over 1 week
      - Database Lock to Top-line analysis delivery in less than1 week
      - Database Lock to Final analysis delivery (including PK results) in just over 2 weeks
      - CSR finalized within 6 weeks of Final analysis delivery

    ** This case study does not reflect SDC's standard timelines for projects; however, it accurately reflects the team's efforts for this particular project.

  • Results Driven Teamwork. Partnership Success Story: Closeout of 8 Clinical Studies

    Integrated, high-performance teams create stellar results. Knowing this, the SDC team creates highly collaborative relationships and seamless interaction with clinical operations. Our clinical partners feel that working with SDC is more like having their own in-house biometrics team, rather than working with an outsourced vendor. Recently, SDC demonstrated this seamless interaction by producing the following results on a series of 8 studies with the same clinical operations partner for 5 separate Sponsors:

    Chart explaining topline reporting

    Key Highlights

    • Combination of EDC and paper-based studies
    • All 8 studies were database locked within one 5-week period
    • Produced topline analysis in 3 business days or less from database lock for all 8 studies
    • Produced final analysis packages in 9 business days or less after database lock for all 8 studies
  • A Regulatory Support Success Story: Full Support and Representation

    From pre-application through post-approval, SDC has extensive experience facilitating communication for our clients with institutional review boards (IRBs), the FDA, and other regulatory authorities. Whether filing a submission or preparing for an upcoming regulatory meeting, our experienced team will offer our full support and representation to help our client's program succeed. An example of this support is listed below:

    Case Details

    • Multicenter global EDC study with clinical duration of over 2 years
    • Complex adaptive study design was developed balancing multiple objectives including time and cost constraints
    • Enrollment of over 100 subjects with 14 study visits

    Key Highlights

    • SDC was intimately involved in developing a new clinical endpoint, inclusion/exclusion criteria and performing detailed power calculations
    • Provided full client representation and support with regulatory agencies
    • Study design and corresponding SAP were approved by multiple international regulatory agencies
    • Seamless interaction with sponsor and multiple clinical operations groups
  • A Post-Hoc Analysis Success Story:
    Providing Top-Tier Statistical Analysis Services

    SDC is fully committed to providing clients with top-tier service throughout the entire clinical trial process. We also understand that additional support will sometimes be necessary once a study is complete to help guide our client's product towards approval. Post-hoc analysis can be critical to the success of any clinical phase program and our experienced team is onboard to offer their support in cases like the following:

    Case Details

    • Completed multicenter phase II adaptive study including an interim analysis
    • Study included enrollment of over 200 subjects
    • 60+ page CRF with subject diaries collected throughout the study
    • Upon study completion post-hoc analysis was needed to support moving forward into phase III studies

    Key Highlights

    • Demonstrated commitment to customer service delivering post-hoc analysis over a period of several months
    • SDC biostatistics team was responsive to all requests with most being fulfilled within a single business day
    • Extensive analysis led to delivery of over 200 statistical tables in total
    • Post-hoc support from SDC allowed client to clearly understand and communicate their results to regulatory agencies and potential partners