Data Management – StatForce Limited

StatForce Data Management processes are designed to provide standards for how work will be completed yet offer the flexibility to customize our support for the needs of your study. Our goal is to ensure your data quality through well-designed data collection, data cleaning, and data management.

We have specialized teams that support either early development studies or later phase studies. These studies often require cohort-based safety reviews to allow the study to proceed to the next cohort. We have the experience and processes needed to quickly clean the data and provide custom reports for the safety reviews.

Data Management Plan (DMP)

StatForce utilizes in-house developed templates as a starting place to customize and elaborate the details for your study. The DMP is intended to discuss all things data-related, spanning from database development through data lock and study archive. StatForce will version-control the document, but the DMP is also intended to be a “living” document throughout the duration of the study.

Data Quality Review Plan

StatForce develops a data quality review plan specific to the needs of each study. This plan defines data review being conducted beyond the CDMS data checks. The defined reviews utilizing data extracts and reports are supported by a set of smart listings. These smart listings have been developed to support two goals, data quality, and efficiency. They support ongoing data review by keeping track of the study teams review and flagging any changes to previously reviewed records. This eliminates the inefficiencies of having to manually keep track of previous records and increases quality because any data modifications are identified, and another review is initiated.

EDC Development

StatForce staff are trained to build and support databases in the Veeva EDC system. Understanding the type of data collection necessary may be equal to or more important than the scope or size of the study. Our DM team will collaborate with the study team through each step of database development, starting with a review of form specifications and once developed an online form review will be conducted. We take the time to review the forms with site personnel to provide a chance to suggest changes that would ease data entry. This step, which is not done by most CROs, helps promote data being entered correctly the first time. Once the forms are approved, we will add field level data checks and field and form skip logic.

StatForce has trained EDC developers to support both the initial build and any mid-study changes. Based on our experience, having internal builders helps us maintain the flexibility and efficiencies needed to not compromise quality when we need to release updates quickly. All data checks and skip logic will be tested, by StatForce during our UAT step. Your study team is offered the opportunity to also perform user acceptance testing (UAT) on the database.

StatForce provides support for all studies with data entry guidelines available for online training to help site staff should the need arise. We also support the training of all study team members and can customize training needs by role or training format. Investigator meetings hosted presentations and pre-recorded training videos are some ways training may be supported at your preference.

Local Labs

We have extensive experience supporting the use of local labs. Local labs present unique challenges for collection and management, because of the need to assign the appropriate normal ranges for each lab test, which can vary based on local lab, sex, age, fasting, and the normal ranges effective date.

Data Metrics & Reporting

StatForce generates a significant number of data metrics, data cleaning, and data review reports daily. All these reports are stored in a repository that is available to the entire study team. This will allow all users to see the status of the entry and cleaning, without the need to request and wait for the information.

Coding

Our team supports medical coding using the MedDRA (by unique terms) and WHO Drug Global (by unique medication, indication, route, and country) dictionaries. Terms are coded within Veeva CDMS utilizing the coding module. These dictionaries are updated twice a year, and if needed our team can support up-versioning all of the coding to the newer version.

Medical Device & Diagnostics

Medical devices and diagnostics play a crucial role in the detection, prevention and treatment of a wide variety of health issues. At StatForce, we recognize that the clinical trial and approval process for a device or diagnostic is different than the drug development landscape. To help navigate the terrain, we bring a top device CRO team of experienced and qualified professionals to support your study in this cutting-edge market segment.

StatForce has a deep understanding of the regulatory requirements, operational guidelines, and safety considerations to successfully advance your medical device or diagnostic product. We have an impressive record in conducting pilot, pivotal, and post-approval studies. StatForce has the expertise and resources to support your unique and complex developmental needs. For success in your medical device or diagnostic study – and to improve the health and extend the lives of patients worldwide – StatForce is your full service CRO partner.

Cardiovascular

Developments in Cardiovascular research are resulting in a reduction of mortality and morbidity while new trends move toward identifying innovative study end points. Thus, new clinical trials related to Cardiovascular will need to be more nuanced.

The strategy for groundbreaking studies focused on Cardiovascular would be creating study designs with alternative end points, which are more nuanced than the traditional mortality end point and are both quantifiable and relevant to the needs of patients and to the interests of other medical care stakeholders.

Our history in cardiovascular research spans thousands of sites globally and has gathered data from hundreds of thousands of patients. This extensive history, combined with our capacity for innovative trial design and an understanding of cardiovascular research, makes us your ideal CRO partner in creative and strategic trial design for your heart failure study.