accelerating hope Protecting your endpoint
Empowering Clinical Data Services
Driving data quality. Bringing life changing treatments to patients. Accelerating clinical trial research. Accelerating Hope.
Revolutionizing clinical data - our service solutions
Data Management Consulting
Every clinical trial is unique, which is why AgileDM Clinical Consulting provides customized consulting services tailored to your specific needs. Whether you require full-service support or targeted assistance in specific areas, our team is here to guide you every step of the way. We pride ourselves on our flexibility and commitment to your success in clinical research.
Case Report Form (CRF) Design
Reviewing a study protocol and quantifying the required and necessary data fields and datasets to fulfill study endpoint needs can be challenging. At AgileDM Clinical Consulting, we will collaborate and provide our guidance and expertise to ensure your clinical trial database meets all necessary data analysis requirements. Our experienced team will work closely with you to develop CRF design specifications.
Database Development Oversight
Our team of experts will work with EDC database build vendors and liaise with the collective team to review database documentation, provide guidance and support throughout the database build process,and perform EDC user acceptance testing (UAT) activities. Additional services include (but are not limited to): EDC user administration, navigating through the database archival process, final EDC vendor account close out activities.
Data Review and Reconciliation
Cleaning data is essential and critical for good data analysis. AgileDM Clinical Consulting can support manual data review, line listing data review, lab reconciliations, serious adverse event (SAE) reconciliation, query generation, query response review, and query close out. Additional services include (but are not limited to): Developing edit check specifications, creating data review plans/data review guidelines, review/authoring of data management plans (DMP), and tiered data cleaning approaches.
Medical Coding
We can help with MedDRA and WHODrug medical terminology coding. Additional services include (but are not limited to): Helping to navigate procuring dictionary licenses, up-versioning approaches (including using the MedDRA Version Analysis Tool (MVAT) and WHODrug Change Analysis Tool (CAT).
Data Management SAS Programming
Leveraging the use of SAS programming to create customized data review listings and data cleaning tools (such as a clean patient report and EDC metrics) can provide better insight on the status of the data cleaning that pulls together all key datasets for a better understanding of progress from the subject, site, and overall study level. Additional services include (but are not limited to): Data transfer agreement (DTA)/specifications (DTS) development/review, data transfer review (test and production), and intelligent, customized missing pages report.
Database Transition | Rescues
Transitioning database and data management service requires a methodical and tactical approach. AgileDM Clinical Consulting will provide guidance to all involved parties, facilitate discussions, and develop a customized rescue transition plan.
Data Management Project Oversight
We specialize in providing expert project management and oversight over the collection of data and data cleaning for clinical trials. Our experienced team ensures that every phase of your trial is executed with precision and efficiency. AgileDM Clinical Consulting can oversee data management activities supported by Contract Research Organizations (CROs) and/or in-house sponsor data teams. We understand the complexities involved in clinical research and are dedicated to delivering results on time and within budget. Additional services include (but are not limited to): Verifying the integrity of clinical data collected, providing strategic data cleaning planning for focused data cleaning (i.e. Interim analysis, New Drug Application (NDA) submissions, etc..), and Trial Master File (TMF) review. Let us help you navigate the clinical trial landscape with confidence.
About AgileDM Clinical Consulting
Our Team
At AgileDM Clinical Consulting, we have assembled a team of talented and dedicated professionals who are passionate about improving healthcare through accurate and clean data. Our team of clinical data science and technical professionals, all of whom bring unique skills and perspectives to our work, will support and develop clinical data management strategies to achieve our combined goals to better patient outcomes. Accelerating Hope.
Sheila Ilano-Antonio, President and Founder
Sheila Ilano-Antonio is the President and Founder of AgileDM Clinical Consulting. She has close to 30 years of clinical research industry experience specializing in clinical data management. Sheila earned her Bachelor of Science degrees in both Biochemistry/Chemistry and Psychology from the University of California, San Diego (UCSD). Sheila is well-known as a highly driven technical subject matter expert for managing clinical trial data, SAS programming, and EDC database design and development. She has been a key leader at various contract research organizations (CROs) in developing the mission, values, and key strategic goals to create efficient and driven clinical data management teams. Sheila develops programs that focus on thorough technical trainings, as well as effective and positive communications which lead to overall data quality and integrity.
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