• Biospecimen SolutionsPrecision Value & HealthCareers
    P_ForMedicine_no_tag_RGBP_ForMedicine_no_tag_RGBP_ForMedicine_no_tag_RGBP_ForMedicine_no_tag_RGB
    • Clinical
      Trial Services
        • Overview
            • Oncology Clinical TrialsImage

              Oncology Clinical Trials


              Through 20+ years running successful oncology trials, we’ve developed a unique blend of proprietary technologies, flexible processes, and creative problem solving abilities that advance even the most challenging clinical development programs.

              • Rare & Orphan DiseaseImage

                Rare & Orphan Disease


                With experience built on 150+ orphan disease projects covering 80+ rare diseases, we know how to anticipate logistical and regulatory obstacles and craft bold solutions that drive rare disease development programs.

        • Global Clinical Trial Support –
            • North & South America –
              • Oncology Clinical TrialsImage

                Oncology Clinical Trials


                Through 20+ years running successful oncology trials, we’ve developed a unique blend of proprietary technologies, flexible processes, and creative problem solving abilities that advance even the most challenging clinical development programs.

            • Europe –
              • Oncology Clinical TrialsImage

                Oncology Clinical Trials


                Through 20+ years running successful oncology trials, we’ve developed a unique blend of proprietary technologies, flexible processes, and creative problem solving abilities that advance even the most challenging clinical development programs.

            • APAC –
              • Oncology Clinical TrialsImage

                Oncology Clinical Trials


                Through 20+ years running successful oncology trials, we’ve developed a unique blend of proprietary technologies, flexible processes, and creative problem solving abilities that advance even the most challenging clinical development programs.

        • Clinical Trial Management –
            • Study Start-up & Feasibility –
              • Oncology Clinical TrialsImage

                Oncology Clinical Trials


                Through 20+ years running successful oncology trials, we’ve developed a unique blend of proprietary technologies, flexible processes, and creative problem solving abilities that advance even the most challenging clinical development programs.

            • Project Management –
            • Patient Recruitment –
            • Personalized Clinical Trial Operations –
            • Biometrics –
            • Medical & Safety Monitoring –
            • Clinical Data Management –
            • Medical Writing –
        • Clinical Development Strategy –
            • Clinical Development Planning –
              • Oncology Clinical TrialsImage

                Oncology Clinical Trials


                Through 20+ years running successful oncology trials, we’ve developed a unique blend of proprietary technologies, flexible processes, and creative problem solving abilities that advance even the most challenging clinical development programs.

            • Biomarker Strategies –
            • Cell & Gene Therapy Strategies –
            • CDx Regulatory and Market Access –
        • Clinical Trial Design –
            • Basket & Umbrella Trials –
              • Oncology Clinical TrialsImage

                Oncology Clinical Trials


                Through 20+ years running successful oncology trials, we’ve developed a unique blend of proprietary technologies, flexible processes, and creative problem solving abilities that advance even the most challenging clinical development programs.

            • Biomarker Clinical Trials –
            • Master Protocol Trials –
            • Decentralized Clinical Trials
        • Biostatistics –
            • Statistical Consulting –
              • Oncology Clinical TrialsImage

                Oncology Clinical Trials


                Through 20+ years running successful oncology trials, we’ve developed a unique blend of proprietary technologies, flexible processes, and creative problem solving abilities that advance even the most challenging clinical development programs.

            • Study Design –
            • Data Monitoring Committees –
            • CDISC Programming and Documentation –
            • eCTD Submissions –
        • Clinical Sample Management –
            • Virtual Sample Inventory Management
              • Oncology Clinical TrialsImage

                Oncology Clinical Trials


                Through 20+ years running successful oncology trials, we’ve developed a unique blend of proprietary technologies, flexible processes, and creative problem solving abilities that advance even the most challenging clinical development programs.

            • Global Specimen Transport and Biostorage –
            • Sample Processing –
            • Kitting –
        • Training
            • Oncology Clinical TrialsImage

              Oncology Clinical Trials


              Through 20+ years running successful oncology trials, we’ve developed a unique blend of proprietary technologies, flexible processes, and creative problem solving abilities that advance even the most challenging clinical development programs.

              • Rare & Orphan DiseaseImage

                Rare & Orphan Disease


                With experience built on 150+ orphan disease projects covering 80+ rare diseases, we know how to anticipate logistical and regulatory obstacles and craft bold solutions that drive rare disease development programs.

    • Specialty
      Lab Services
        • Overview –
            • Immune MonitoringImage

              Immune Monitoring


              Leverage sophisticated immune monitoring approaches, including flow cytometry, Epiontis ID immune cell phenotyping, and cytokine profiling, to characterize the immune cells in your samples and understand their impact on patient biology.

              • Tissue & Liquid BiopsyImage

                Tissue and Liquid Biopsy


                Obtain a detailed molecular view into patient biology with a range of tissue and liquid biopsy technologies, including our proprietary ApoStream platform which can isolate and enrich circulating tumor cells for downstream analysis.

        • EU Contract Research Organization –
        • Immune Monitoring –
            • Immune Monitoring by Flow Cytometry –
              • Immune MonitoringImage

                Immune Monitoring


                Leverage sophisticated immune monitoring approaches, including flow cytometry, Epiontis ID immune cell phenotyping, and cytokine profiling, to characterize the immune cells in your samples and understand their impact on patient biology.

            • Immune Cell Phenotyping by Epiontis ID –
            • Cytokine Profiling –
            • Gene Expression Profiling –
            • ELISpot and FluoroSpot –
            • Custom Assays –
        • Flow Cytometry –
            • Immune MonitoringImage

              Immune Monitoring


              Leverage sophisticated immune monitoring approaches, including flow cytometry, Epiontis ID immune cell phenotyping, and cytokine profiling, to characterize the immune cells in your samples and understand their impact on patient biology.

              • Tissue & Liquid BiopsyImage

                Tissue and Liquid Biopsy


                Obtain a detailed molecular view into patient biology with a range of tissue and liquid biopsy technologies, including our proprietary ApoStream platform which can isolate and enrich circulating tumor cells for downstream analysis.

        • Genomics –
            • NanoString Assays –
              • Immune MonitoringImage

                Immune Monitoring


                Leverage sophisticated immune monitoring approaches, including flow cytometry, Epiontis ID immune cell phenotyping, and cytokine profiling, to characterize the immune cells in your samples and understand their impact on patient biology.

            • ddPCR –
            • qPCR –
            • NGS –
            • Fluorescence In Situ Hybridisation (FISH) / ISH –
        • Tissue & Liquid Biopsy –
            • ApoStream – CTC and Rare Cell Isolation for Liquid Biopsy
              • Immune MonitoringImage

                Immune Monitoring


                Leverage sophisticated immune monitoring approaches, including flow cytometry, Epiontis ID immune cell phenotyping, and cytokine profiling, to characterize the immune cells in your samples and understand their impact on patient biology.

            • CTC / cfDNA / Exosome Analysis –
            • Multiplex Immunofluorescence –
            • Immunohistochemistry –
            • Fluorescence In Situ Hybridisation (FISH) / ISH
            • Pathology Services –
            • NanoString Assays
        • Bioanalytical Testing –
            • Immunogenicity Testing –
              • Immune MonitoringImage

                Immune Monitoring


                Leverage sophisticated immune monitoring approaches, including flow cytometry, Epiontis ID immune cell phenotyping, and cytokine profiling, to characterize the immune cells in your samples and understand their impact on patient biology.

            • PK Assays –
            • ADA Assays –
            • MesoScale Discovery (MSD) Assays –
            • Quanterix SIMOA –
            • ELISA
        • Cytokine Analysis –
            • ELISA –
              • Immune MonitoringImage

                Immune Monitoring


                Leverage sophisticated immune monitoring approaches, including flow cytometry, Epiontis ID immune cell phenotyping, and cytokine profiling, to characterize the immune cells in your samples and understand their impact on patient biology.

            • MesoScale Discovery (MSD) Assays
            • Luminex –
            • Quanterix SIMOA
        • Preclinical Target and Biomarker Validation –
            • Cell Based Assays –
            • Target Expression – XpressWay Profiles –
            • Tissue Cross-Reactivity –
            • Fluorescence In Situ Hybridisation (FISH) / ISH –
            • Multiplex Immunofluorescence –
            • Immunohistochemistry (IHC)
        • Biospecimens
            • Immune MonitoringImage

              Immune Monitoring


              Leverage sophisticated immune monitoring approaches, including flow cytometry, Epiontis ID immune cell phenotyping, and cytokine profiling, to characterize the immune cells in your samples and understand their impact on patient biology.

              • Tissue & Liquid BiopsyImage

                Tissue and Liquid Biopsy


                Obtain a detailed molecular view into patient biology with a range of tissue and liquid biopsy technologies, including our proprietary ApoStream platform which can isolate and enrich circulating tumor cells for downstream analysis.

        • Sample Processing
        • Global Specimen Transport & Biostorage
    • Data
      Sciences
        • Overview
            • BiostatisticsImage

              Biostatistics


              Seasoned biostatisticians and statistical programmers support every phase of your trial, from study design for small, rare disease trials to regulatory submissions, all backed by meticulous documentation.

              • Computational BiologyImage

                Computational Biology


                Domain experts from our QuartzBio team utilize integrated and harmonized data and tailored AI solutions to drive preclinical and clinical development, including patient stratification, signature development, predictive modeling of drug response, and MOA characterization.

        • Biostatistics
        • Clinical Data Management
        • Biometrics
        • QuartzBio –
            • Biomarker Data Management –
              • BiostatisticsImage

                Biostatistics


                Seasoned biostatisticians and statistical programmers support every phase of your trial, from study design for small, rare disease trials to regulatory submissions, all backed by meticulous documentation.

            • Virtual Sample Inventory Management –
    • Therapeutic &
      Research Expertise
        • Overview
            • By Specialty Area
              • Global-clinical-trial-support-2Image

                Global Clinical Trial Support


                Sample processing labs, clinical trial sites and offices in five continents provide the clinical reach and scale to manage complex global programs.

            • Oncology and Immuno-Oncology
              • Oncology Clinical Trials
            • Rare & Orphan Disease
              • Global-clinical-trial-support-2Image

                Global Clinical Trial Support


                Sample processing labs, clinical trial sites and offices in five continents provide the clinical reach and scale to manage complex global programs.

            • Cell & Gene Therapy
              • Cell Therapy
              • Gene Therapy
              • Cell and Gene Therapy Manufacturing
            • CNS & Neuroscience
              • Global-clinical-trial-support-2Image

                Global Clinical Trial Support


                Sample processing labs, clinical trial sites and offices in five continents provide the clinical reach and scale to manage complex global programs.

            • COVID-19
            • AutoImmune & Allergy
            • Pediatric
            • Companion Diagnostics
        • By Research Phase
        • Preclinical Development –
        • Early Phase Trials (I-IIa) –
        • Late Phase Trials (IIb-III) –
    • News &
      Insights
        • Blog –
            • iStock-945738094Image

              Blog


              Industry trends and best practices from Precision experts

              • shutterstock_1033743346Image

                Resources


                A searchable hub featuring the latest Precision case studies, white papers, capabilities brochures and more.

        • Resources –
        • Thought Leadership –
        • News –
            • iStock-945738094Image

              Blog


              Industry trends and best practices from Precision experts

              • shutterstock_1033743346Image

                Resources


                A searchable hub featuring the latest Precision case studies, white papers, capabilities brochures and more.

        • Events –
            • iStock-945738094Image

              Blog


              Industry trends and best practices from Precision experts

              • shutterstock_1033743346Image

                Resources


                A searchable hub featuring the latest Precision case studies, white papers, capabilities brochures and more.

    • About
      Us
        • Our Passion –
            • Patient RecruitmentImage

              Our Passion


              What we do, why we do it and the principles that guide us every day.

              • meet-our-peopleImage

                Meet Our People


                We are devoted professionals with deep expertise in translational science, clinical trials and data sciences.

        • Meet Our People –
        • Careers
        • Regulatory Information –
            • Patient RecruitmentImage

              Our Passion


              What we do, why we do it and the principles that guide us every day.

              • meet-our-peopleImage

                Meet Our People


                We are devoted professionals with deep expertise in translational science, clinical trials and data sciences.

    • Contact
      Us
    • Home
    • Clinical Research EDC: Tips to Go Live on Time

    Clinical Research EDC: Tips to Go Live on Time

    by Michelle Martell on November 11, 2021 — 6 minute read

    Clinical Research EDC timeline development

    Proactive planning and cross-functional collaboration help streamline the design and build of an efficient, effective clinical trial data collection platform

    Electronic data capture (EDC) systems are essential technologies for collecting, storing, and analyzing patient data in clinical trials. Building an EDC system is a shared responsibility among multiple stakeholders—including the sponsor, CRO, software vendor, project management, clinical, clinical science analytics & insights, medical monitors, safety, and biostatisticians—making timely go-live a team effort. Though it may seem complex, EDC go-live is a sequential process that, if followed, can avoid costly delays.

    In our experience, sponsors may not always consider the myriad factors that drive the build of their EDC. In this article, we provide insight into the key aspects of EDC design and build to help sponsors gain clarity around the steps involved to help them optimize their workflows.

    Factors that Drive EDC Timelines

    EDC builds follow a disciplined process that begins with the execution of a sponsor work order and ends with EDC go-live. Once the sponsor work order has been executed and the sales order with the EDC vendor has been finalized, the database build can begin.

    A critical consideration in the EDC timeline is the status of the protocol. Ideally, the protocol has been finalized. If the protocol is stable but not yet final, this introduces potential risk to both the timeline and the bottom line due to costly rework. Electronic case report form (eCRF) development can begin but is subject to re-work and multiple rounds of review if the protocol changes. Proactively factoring in time for future feedback and eCRF specification finalization in anticipation of changes is helpful for managing expectations and staying on track.

    You play an important role in keeping clinical trial EDC timelines on track

    The EDC build involves a number of well-defined development phases, each of which can be rate-limiting without intelligent planning. By understanding the detailed timeline requirements, providing timely feedback, and collaborating openly with the partner CRO, expected database open dates can be met more confidently.

    Defining the eCRF design specifications: Ensuring the eCRF design specification process is well-understood by all stakeholders before starting this process helps maintain focus on content and analysis. Keeping the system simple yet flexible and designing it with all users in mind helps ensure ease of use and a seamless workflow, both of which contribute to reducing entry errors and enhancing data quality. At Precision for Medicine, we adhere to pre-approved and reviewed design specifications rules, which reduce extraneous effort and timeline crunches. In this phase, it is important to check that decision-makers from each functional group responsible for eCRF can commit to review periods and attend review meetings. With each successive review meeting, there should be fewer comments and change requests, streamlining finalization of the eCRF design specifications.

    Aligning on database configuration specs: Determining the key elements of a database upfront can have a positive waterfall effect on the rest of the process. Elements such as subject numbering conventions, site numbering, and medical coding dictionary versions are important structural elements of a database. Altering these configurations in late-stage development can have costly downstream implications and may delay go-live.

    Programming the eCRF: Once all stakeholders have signed off on the eCRF design specifications, screen programming can begin. The better the specifications are, the better the programming will be. If the forms are stable, some programming can be done in parallel, but there is inherent risk in working in a non-linear fashion. A common pitfall involves trying to shave down timelines by cutting corners or skipping steps in the programming protocols.

    Establishing edit check specifications: Edit checks are automated, auditable processes for assessing the content of a data field against its expected properties to reduce the likelihood of errors in data entry. Establishing the specifications for edit checks should only begin when the eCRFs are stable and fully programmed.

    Programming edit-checks: Once the edit check specifications are finalized, programming of the edit checks can start. The approved specifications drive what will be built in the EDC for go-live. While changes are expected and should be built into the overall timeline, substantive changes will impact the go-live date.

    Performing user acceptance testing (UAT): The length of time that should be allotted to this phase of the EDC build will depend on the level and intensity of the sponsor’s UAT process. Each EDC platform has its nuances, and each build is unique. Consequently, it is important to understand the sponsor’s and the team’s experience with the platform to support efficient UAT. In our experience, it is useful to have each team member take the EDC eLearning as a prerequisite, so they understand how to navigate the system and perform data entry prior to UAT.

    Integrating the interactive response technology (IRT) system: Sponsors often ask if IRT can go live in advance of EDC. The answer to this question depends on what pieces of the EDC platform are needed to build out the IRT system and which fields will be integrated. At Precision for Medicine, we recommend limiting integrated fields to only those that add discrete value.

     

    We generally advise against integrated data from external vendors, like safety lab data or other biomarker data

    These integrations require substantial effort and rigorous validation which competes with—and distracts from—focused EDC go-live efforts and may create unnecessary data redundancy. Rather than trying to pull disparate data sources into an EDC system, sponsors may want to consider purpose-built data aggregation platforms such as QuartzBioSM that are specifically designed for multiomics data integration and interrogation.

    See the importance of timely approvals for an on-time go-live of your EDC
    Key Takeaway for and Effective EDC Go Live

    Ultimately, the goal of an EDC build is to create a clean, simple, efficient, straightforward database that can be analyzed. Intelligent planning and intentional multi-stakeholder commitment are fundamental to successfully meeting the EDC go-live timeline without sacrificing quality. Having well-thought-out specification blueprints helps sponsors, software developers and CROs proactively plan and execute the design, build, and launch of an EDC system. In addition, developing collaborative partnerships and adhering to review and timeline commitments across extended teams helps streamline the process and ensure the quality and usability of the final product.

    At Precision for Medicine, we have extensive experience working with sponsors on designing and building EDC systems, either as a full-service clinical trial solutions provider or a functional service provider. To learn more about our clinical data management services and our EDC experience, click here.

     

    About the Author

    Michelle Martell is an Executive Director of Data Management with over 20 years of data management experience, having worked in both the CRO and pharmaceutical company space. A Certified Clinical Data Manager (CCDM), Michelle excels as an outside-the-box thinker who emphasizes quality and good clinical practice, while respecting client needs, budget, and timeline considerations. With proven success as a study leader, Michelle also contributes regularly to the technical aspects of the job, including database builds and programing from study start up to database lock. She has successfully managed multiple studies across several therapeutic areas and deployed a number of clinical data management systems.

    Precision for Medicine is part of the Precision Medicine Group, an integrated team of experts that extends Precision for Medicine’s therapeutic development capabilities beyond approval and into launch strategies, marketing communication, and payer insights. As one company, the Precision Medicine Group helps pharmaceutical and life-sciences clients conquer product development and commercialization challenges in a rapidly evolving environment.

    Visit the website
    Clinical Trial Services
    • Overview
    • Global Clinical Trial Support
    • Clinical Trial Management
    • Clinical Development Strategy
    • Clinical Trial Design
    • Biostatistics
    • Clinical Sample Management
    • Clinical Research Organization
    Specialty Lab Services
    • Overview
    • Immune Monitoring
    • Flow Cytometry
    • Genomics
    • Tissue & Liquid Biopsy
    • Bioanalytical Testing
    • Cytokine Analysis
    • Biospecimens
    • Sample Processing
    • Global Specimen Transport & Biostorage
    • Contract Research Organization
    • Bioanalysis
    • Neutralizing Antibody (NAb) Assays
    • PBMC Processing
    Data Sciences
    • Overview
    • Biostatistics
    • Clinical Data Management
    • Biometrics
    • QuartzBio
    • Virtual Sample Inventory Management
    Therapeutic Expertise
    • Overview
    • Preclinical Development
    • Early Phase Trials (I-IIa)
    • Late Phase Trials (IIb-III)
    • Oncology and Immuno-Oncology
    • Rare & Orphan Disease
    • Cell & Gene Therapy
    • Neurology
    • COVID-19
    • Autoimmune & Allergy
    • Pediatric
    • Companion Diagnostics
    About Us
    • Our Passion
    • Meet Our People
    • Careers
    • Regulatory Information

    News & Insights
    • Publications
    • Case Studies
    • Thought Leadership
    • News
    • Events
    © 2022 Precision Medicine Group, LLC. All rights reserved. Privacy Policy    GDPR