Johns Hopkins Chooses VISION™ for COVID-19 Studies

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.

Prelude Dynamics partners with Johns Hopkins on three COVID-19 Studies

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!


New EDC Feature for POC and Phase 1 studies

Prelude announces a new EDC feature that streamlines data entry for Proof of Concept (POC) or Phase 1 studies. Multiple Subject Data Entry allows users to enter data for multiple subjects at the same time using a single form. Users can configure this form at the site level by selecting the subject level forms and fields for entry. Filters can then be used to select a subset of subjects for processing.

Screen shot of Multiple Subject Data Entry

The VISION™ EDC will post the data to the each subjects’ eCRFs once the data entry is complete. The system will also update the audit trail so that the field changes are attributed correctly. If errors or warnings resulted from the data entry, the subject list page can used to quickly identify those subjects and forms.

This feature is very useful when values are collected for subjects in rapid succession e.g., taking everyone’s vital signs or (for animal studies) counting fleas. In such instances, data is typically manually entered on a clipboard and then transcribed to EDC. Transcription typically requires navigating from subject to subject, which can be error prone and time consuming.  Use of Multiple Subject Data Entry eases transcription and facilitates using the EDC as eSOURCE.

The new Multiple Subject Data Entry feature was designed to offer an extreme level of efficiency for users. It is easy to configure and easy to use. Ask your Prelude project manager today about including multiple subject data entry in your next POC or Phase 1 study! This feature in combination with our powerful EDC, CTMS and CDMS functionality truly makes the VISION™ EDC an industry leader.

Performing a Remote Audit of your EDC Vendor

There has been a great deal of discussion lately on remote trials, remote monitoring, e-consent, etc., in the context of COVID-19. Another great topic worth discussing is remote auditing. Sponsors and CROs typically conduct on-site audits of their EDC vendors on a bi-annual or tri-annual basis, but what if that can’t be done on schedule? Add in the fact that experienced auditors are amongst the most vulnerable population, and the need for an alternative becomes painfully obvious. 

Recently, Prelude Dynamics has experienced an increase in Requests for Information and Vendor Qualification Questionnaires. Instead of becoming overwhelmed by filling in the same information multiple times, we have come up with a solution to streamline the process. We created a proprietary Remote Audit Response document for distribution to our Sponsor and CRO clients. It is a comprehensive document which will provide a suitable baseline for remote audits going forward. If you’re interested in receiving a copy, Contact Us. 

Remote Audit Checklist

We recently attended a webinar on the topic of remote audits so that we could provide helpful information to our Sponsor and CRO clients. Here are the most important tips we learned:  

Use a risk-based approach to identify providers to audit 

  • The FDA uses a risk formula to determine inspection priorities. 
  • It may be appropriate to assess less risky organizations and sites using a questionnaire. Software-as-a-Service (SaaS) providers are very good candidates for remote audit. 
  • Consider auditing 10% of the riskiest providers. The complexity of the service provided and proximity to market (GMP) factor into risk. 

Establish protections for Intellectual Property and methods of communication and data transfer. 

  • Non-Disclosure agreements protect both Sponsors/CROs and vendors and promote the flow of information. 
  • Test web-based video teleconferencing platforms and data transfer mechanisms in advance. 

Conduct the remote audit in phases. 

  • Ask the provider for an initial set of documentation and use that as a basis for a second request for information. Establish a deadline for submittal. 
  • The initial set should include indices (such as an SOP list), Organization Charts and Quality Manuals. 
  • Plan subsequent phases to address issues and questions that remain after the initial set has been reviewed. 

Formulate and communicate the agendas for additional phases in advance. Both parties should confirm receipt of all audit related communications. 

  • Requests for information should not be all inclusive. Request subsets such as specific training records, validation results and backup and restore evidence. 

Conduct opening and closing meetings to review status and remaining agenda items. 

  • If interviews with specific personnel are required, collaborate on scheduling. 

Conduct a closeout meeting to discuss observations. Only assign severities in the final report. 

  • Set realistic timeline for audit response. Define how results of any CAPAs will be reviewed (e.g., video telecon, copies of documentation). 

We are ready to collaborate with you on your next remote audit of Prelude Dynamics! 

Prelude Dynamics offers process improvements to help you cope with this new normal. Prelude Dynamics




New Reality of Remote Audits

This morning, Prelude attended a meeting on the new reality of remote audits and inspections. In the past, remote auditing of sites was viewed as a nice capability. As many in the industry are now learning, remote capabilities are now a necessity. Sites that collect data on paper will need to scan all their documents into digital formats as fast as possible. This process can present many issues including legibility, legality, and availability of documents (documents located in locked down facilities will be unavailable for the foreseeable future).

Auditors understand the struggles for documentation at this time, and they will be giving sites more lead time as well as more time for the actual inspections. However, a simple increase in time permitted for an audit is not a sustainable solution. This method is merely a Band-Aid. Recording studies on paper is no longer sustainable. The time to switch to a digital platform is now. Let Prelude’s team of certified data managers help you transition to a more efficient and more effective eCRF database. We are working with companies around the world to meet industry standards and deadlines to ensure a brighter future for all.


How to Make the Most of Remote Trials During COVID-19

For years, technology’s detractors have bemoaned the loss of in-person interaction. While we admit this has been an issue on occasion, it’s now an asset to moving important clinical research forward. 

Many human and animal health studies are either still done on paper or require labor-intensive source document verification (SDV). If sites are not using technology for direct data entry, in-person site visits are required to track the data throughout the life of the study.  

Another prevalent challenge under current “social distancing” norms is to obtain signatures remotely that are CFR 21 Part 11 compliant. Many data managers are considering eliminating DocuSign as insecure. Adobe Sign has likewise been found by some to be untrustworthy as PDFs can be changed after the original signing. The print/sign/scan method is outdated and cost prohibitive. Many team members do not have printer/scanner combinations in their home office.  

Finally, many GCP studies are struggling right now due to a lack of study participants coming into their clinics or bringing their pets back for follow-ups. Enrollment and compliance with a visit schedule are not feasible in these uncertain times where many patients aren’t even allowed in the door.  

Given the challenges above, a robust electronic data capture system (EDC) can be more valuable to clinical trials than ever before. Prelude’s EDC, VISION, has been officially CFR 21 Part 11 compliant for close to two decades.  The system has been purposefully designed to make direct data entry as seamless as using paper, with eCRFs capable of mirroring the same look and feel as a paper form.  

Prelude’s new ePro application gives patients and pet owners unprecedented access to their own forms so that they can follow up on their enrollment schedule from their own home, in many cases eliminating the need to visit clinical sites.