Continuing Studies, Database Locked

  • A pivotal study of trial implant v SOC for the treatment of knee-joint surface lesions were initiated at OUS sites, including Italy and Serbia in September 2017, and in USA and Israeli sites in 2018, with a planned duration of ~5 years. Due to very short timeline in surgical environment during which a very large amount of data was collected to randomize patients, a native app was created for use across up to 30 global sites.
  • IVRCC was approved and used as primary IWRS vendor for several major sponsor Tobacco research studies, randomizing eligible subjects and dispensinginvestigational products.  Four studies were deployed throughout the year at US sites, and a total of five were successfully locked on-time and archived by the end of the year. One was continuing, and more are planned for Q1 2019 deployment.
  • IVRCC closed out an infectious disease study where IVR for non-WiFi access was utilized for Operating Room access capability for randomization, and IWR was needed for site user data entry and dispensation of IP.
  • Gastroenterology IBS exploratory study using IWRS for study management and IWRS & IVRS for subject ePRO collecting clinical trial material dosing and Bristol Stool Scale symptoms was closed out in 2018.
  • Two dermatology Acne studies continued enrolling through Q1, with continued drug dispensation ending in June. IVRCC’s IWRS was used for registration and randomization, with FTP transfer to the EDC final database. Data locks were completed.
  • We worked on a Knee Osteoarthritis associated with Bone Marrow Lesions study in Australia and US closeout of IWR/IVR for ePRO to collect concurrent and IP medication dosing.
  • On the Road: IVRCC exhibited at Outsourcing in Clinical Trials New EnglandConference in November 2018, engaging with over 500 attendees and exploring how our core capabilities can be applied in different types of studies and clinical trials. Come meet us at our exhibit booth in Boston, MA, October 2-3, 2019 at Arena’s Outsourcing in Clinical Trials New England 2019.
  • A nearly five year Renal Carcinoma observational non-interventional study conducted for a Fortune 500 pharmaceutical company was scheduled to data lock by the end of 2018.
  • An Oncology Registry in Breast Cancer continued running in US and OUS global locations, including sites in Canada and Italy.
  • We are continuing a 6+ year global (including Denmark, Netherlands, Germany, Italy, Spain and Sweden) Hemophilia FIX infusion study using IWRS for visit and subject management of symptom novel PRN ePRO questionnaire, with automated subject self-registration and data transfer to the client EDC final database.
  • We are continuing to provide support for a global Breast Cancer study, where sites used iPads for study ePRO of FACT-BCand other validated instruments and subject/visit management.
  • IVRCC has had a busy year as we continue to expand our business model, adding data collection in retrospective studies of patients with various cancer diseases. A Retrospective chart review RWE study in Thoracic Oncology was released, with a second retrospective study in a similar indication confirmed for 2019. Programming was suitability configured for the hundreds of data points to be collected.

Privacy and Security

  • We retired our Boca Raton Platform in Florida and have re-located our Technology Platform to the Knoxville, Tennessee area. Our Platform Architect and Platform Operations Manager are residents in nearby communities. While much of our work can be done remotely, we have a more quickly responsive team in Tennessee due to on-site physical presence. Our new home is in the heart of the technology and communications hub of the region.
  • IVRCC released this new interactive platform featuring significant modernization with upgrades in programming and backups, geographic redundancy of data and applications across multiple physical sites, a new disaster recovery model with near real-time mirroring of data and applications for fast response to widespread Internet outages, and new, more efficient software powered to complete product validations and documentation quickly, clearly and in compliance with best-of-class standards.
  • IVRCC complies with and is listed on the EU-U.S. Privacy Shield Framework and the Swiss-U.S. Privacy Shield Framework as set forth by the U.S. Department of Commerce regarding the collection, use, and retention of personal information transferred from the European Union and Switzerland to the United States. IVRCC has certified to the U.S. Department of Commerce that it adheres to the Privacy Shield Principles.
  • Additionally, IVRCC maintains a continuing program to comply with the recent European Union 2018 General Data Protection Regulation (GDPR) for governing the collection, processing, use and storage of personal data as it applies to EU citizens and residents.
  • Updated SSL certificates were universally implemented for all studies and for the IVRCC website.
  • Increased cloud security for project files and client project communications was implemented in 2018 for better protection of sensitive clinical information.

QA, Documentation & Validations

  • IVRCC validation processes were further enhanced via the implementation of powerful automated matrix applications, resulting in shorter timelines to completed validation results, and generation of detailed compliant documentation.
  • IVRCC developed a robust mechanism for allowing auditors easy and secure access to our QA, SOPs and validation documents, through cloud technology.  Clients have been very satisfied with the little to no-travel option for performing audits, resulting in lower costs and quicker audit results and shorter response turnaround times. Several successful audits were conducted by clients throughout the year with no major findings.  Standard Operating Procedures (SOPs) were updated and implemented to further solidify clinical operations.
    Certified Quality Assurance personnel were added to the QA Department.
  • Data Correction Form (DCF) services were provided as a value-added service to increase customer support.
  • Internally custom developed Trial Administrative Module (TAM) and commercially available software tracking tools were utilized to provide automated detailed study audit and application development trails.

Programming & Ease of Use Enhancements

  • IVRCC added Administrative Modules for sites to perform administrative functions for their studies, including study personnel self-setup in order to use the system, with designated third party approval required for access to the study. Administrative access allows for real-time updating and entry of site personnel as they come on-board to the study and removal of dropped-out study participants, ensuring an appropriate level of privacy and security to the study applications.
  • Subject self-registration modules were configured in most studies collecting ePRO. These modules provide ease and privacy for subjects self-registering, the ability to update their own profile information, and options to select preferences for native language, reminders and notifications. Privacy-compliant tracking and reporting was available for both subjects and study personnel.
  • Help Desk Customer Service was increased to provide automated and trained live personnel response globally, 24/7/365, via phone and email, to speed up acknowledgment of assistance needs.  The Help Desk system was further expanded to ensure timely resolution within minutes to hours of a query, based on urgency rating designated by the issue initiator.
  • User Satisfaction Surveys were distributed to recently closed-out application users as an important part of our efforts to continually improve data collection interfaces and intuitive interactive mechanisms for users. This feedback also helps improve automated branching to guide subjects through the study and ePRO, ensuring a high level of good quality, valid entries.
  • IVRCC developed and utilized licensed interactive web-based and mobile versions of EQ5D and other visual analog scale (VAS) instruments for elimination of costly and time-consuming paper methods.  Electronic scales eliminate the labor intensive review process typical in finalizing paper VAS entries.