CVM’s Office of New Animal Drug Evaluation (ONADE) has launched an initiative that will greatly increase the efficiency of the study submission process. They will now allow submissions through read-only access to online databases in lieu of the submission of copies of the data. Prelude Dynamics is participating in this pilot program with two study sponsors, and we are optimistic for successful outcomes in both. The primary advantages of allowing CVM direct study access as opposed to the submission of copies of the data are:
For CVM: With access to the online database they will be able to view the data in a more natural, intuitive way. Spreadsheets do not provide the context that the full database can and are therefore not as suitable. With access to the database, CVM can view all the audit trail information right alongside the source data.
For Sponsors/CROs: Online access eliminates problems with multiple file uploads and file size restrictions that make the current submission process cumbersome. The burden of “packaging up” study data in a eSubmitter-ready format is removed. Submissions will be faster and less costly.
Preliminary results with one EDC system are promising. Both CVM and pharmaceutical companies are enthusiastic for the future of the study submission process.
For studies to participate in the program, some documentation is required up front. Prelude Dynamics has also removed this burden from Sponsors and CROs by offering prepared templates for interested parties. If you are interested, ask your Prelude project manager for a template today! They can help you submit your information to the right people at CVM.
Prelude’s unique eConsent functionality is the latest in a long line of enhancements aimed at eliminating paper from clinical trials. Up until now, most clinicians have obtained owner and subject consent on paper forms that are then uploaded into the system. Now sites can obtain owner and subject consent electronically the same as for any other user signature for the study.Animal Studies
For animal studies, the process for obtaining owner signatures begins with an owner profile added by the site. The owner then logs on and immediately signs an electronic signature agreement. After the generic agreement is signed the owner is able to electronically sign any study-specific consent forms. Once the subject is enrolled the owner is free to fill in their own demographic information as well as any forms that are required for the study such as a dosing schedule or owner diary.
For human studies, brand-new technology has been implemented to attach the signed consent form directly to the appropriate PDF document. No personal data will be collected about the subject until the informed consent is signed electronically by the subject.
The eConsent feature of VISION includes the ability to send (and re-send) notifications to the subject to remind them to sign relevant forms. A notification can also be sent to site personnel to alert them when a form has been signed. The forms can also be provided with multiple language options for studies enrolling non-English-speaking subjects.
An electronic signature is a distinctive mark appended to a document for verification. It offers the same validity as an ink signature yet with an even higher degree of contemporaneousness as it also includes the time/date stamp and logged-on user information. It is a safer, faster, and more cost-effective approach for capturing signatures.
Integrated invoicing is a powerful mechanism for incentivising site participation. It alsoeliminates extraneous trial management activities. What is it and how does it work? This article takes a closer look at integrated invoicing and how it can work for you.
Sites deserve to be paid for completed study activities in a timely manner. Payment milestones such as examination completion, lab result analysis, subject visits are known in advance and documented in the master fee schedule for the study or site. Since these billing milestones are well-defined, the study can be configured to automate the creation and submission of site invoices. This eliminates paperwork for the sites, ensures accuracy, relieves study managers of invoice verification activity and speeds payment.
VISION™’s integrated invoicing functionality allows configuration of invoice line items in a flexible and powerful manner. Examples include:
Study visit completion
Physical exam completion
Lab samples drawn and sent to lab
Invoice line item generation can be tied to field completion, a form’s state (e.g., Reviewed or Finalized), the states of a set of related forms, or a combination of the above. Sites across a study are rarely run the same, and it is not uncommon to see a variation in payment schedules across sites. VISION™ allows the invoiced amount for each line item to be configured for each individual site if desired.
It’s common practice to configure the EDC so that the investigator sign off on each invoice activates submission. This serves as an indication that the investigator has reviewed and approved each invoice. Did you know that VISION™ can also be configured so that the invoice can be annotated when payment has been made? Study monitors and project managers can easily see the real-time status of all invoices using VISION™’s reporting tool.
Streamline trail administration activities by using this powerful feature! Sponsors/CROs who don’t take advantage of integrated invoicing often tell us they wish they had used it.
Prelude Dynamics, LLC, has released some exciting new enhancements to the VISION™ Reports tool. This function of their Electronic Data Capture (EDC) system allows users to view data according to the criteria of their choosing at any point in the study. Reports can be saved, shared with other users, and added to each user’s Dashboard for convenience.
Users can now…
Easily specify report content using a drag and drop interface.
Include data from forms in multiple visit days (e.g., Physical Exams across all visits)
Sort results by any column’s ascending or descending order by clicking on the column header
Filter fields by typing into a field at the top of each column
Download any report into Excel with a new and improved interface
The Reports feature of VISION™ has always been a useful data management solution, and is one of many ways to ensure data ingegrity. All clinical staff have the ability to create sets of reports that help them focus in on important data such as clinical end points. The ability to export these reports is a valuable tool for bio-statisticians and project managers alike. Now, clinical trial conduct and management have gotten even easier with Prelude’s addition of a convenient, new user interface.
Prelude constantly strives to assist the health industry in their pursuit to bring innovative pharmaceuticals to consumers. Stay tuned for even more updates from Prelude as we make it easier than ever to conduct a successful clinical trial.
Prelude Dynamics, LLC, is proud to announce our partnership with Johns Hopkins on three COVID-19 related studies. This new partnership expands on previous collaborations between Prelude and Johns Hopkins in the areas of Traumatic Brain Injury (TBI), multiple sclerosis, and vertigo. Prelude Dynamics’ VISION™ EDC was selected from a field of EDC providers based on advanced system capabilities, our ability to stand up studies in days, and Prelude’s high level of service.
Study 1: Plasma Donor Registry
The first study Prelude and Hopkins are collaborating on is a registry of individuals who have recovered from COVID-19 and are candidates for plasma collection. Once donors are qualified, their Human Coronavirus Immune Plasma (HCIP) can be used in the second and third studies. These follow-up studies are both Phase 2 and will be randomized and double-blinded.
Study 2: Convalescent Plasma as a Preventative Treatment
The second study will investigate the use of convalescent plasma in high risk subjects who have experienced a close contact exposure to a person with COVID-19 but are not yet symptomatic. With an enrollment goal of 150 subjects, the project will study the efficacy and safety of using HCIP as a preventative treatment.
Study 3: Convalescent Plasma to Reduce Complications
The third study will investigate the use of HCIP as a therapy for ambulatory subjects who have tested positive for COVID-19 through an RNA detection test and have at least one symptom. With an enrollment goal of 1,344 subjects, this project will study the efficacy and safety of using HCIP to reduce complications due to COVID-19. In addition to saving lifes, a positive outcome for this trial will mean HCIP has the potential to greatly reduce hospitalization and ICU requirements for COVID-19 patients.
The randomized studies will use VISION™‘s integrated Just-in-Time randomization algorithm as well as our sophisticated masking and source data verification (SDV) functionality . Both studies will be conducted in the US from April 2020 through December 2022. We are excited that Johns Hopkins has chosen our VISION™ EDC for this potentially life-saving work and look forward to successful outcomes!