Business Process Outsourcing

WHITE PAPERS AND CASE STUDIES

• CRO Implements A Successful, Patient-Centric Decentralized Solution For An On-going Clinical Trial During COVID-19

  A mid-sized biotech company was in the middle of conducting an open-label long-term safety study with 137 active patients across 25 sites in the US and Canada. Then the COVID-19 pandemic hit. Rho developed a customized and decentralized solution for their study that would ensure patient safety and data quality while allowing their study to progress according to FDA guidelines for conducting research during this pandemic.

• Simple SOP Updates Every Research Site Needs To Succeed At Remote Monitoring

  Today’s crisis climate is creating a dichotomy in clinical research. As a result, sites are closing, medical facilities are enforcing access restrictions, and there are constant delays or stoppage of non-essential studies. On the other hand, this health crisis is highlighting the critical need for clinical research due to ongoing COVID-19 trials. As a result, clinical researchers are asking questions and seeking workarounds to continue operations in response to site-specific adjustments. One central issue has surfaced — how do we continue to maintain compliance when working from home?

• Building An Online Platform To Fight Counterfeits On Blockchain

  Blockchain technology can be used to build an online platform where manufacturers, retailers, and consumers can come together to authenticate goods that we buy every day. A startup company plans to scale up by working with its manufacturing and retailing partners and building up the platform to fight counterfeit issues and show authentic supply chain information on the blockchain. This would ultimately drive out the counterfeits in the retail supply chain and afford a satisfying shopping experience.

• Droplet Digital Polymerase Chain Reaction

  Leveraging the hyper accuracy of Droplet Digital PCR (ddPCR), viral and gene therapy developers gain additional confidence in tittering assays and vector copy number determination.

• Three Options To Viral Vector Manufacturing Capacity

  Industry thought leaders working in the viral vector manufacturing space recently participated in a Virtual Think Tank (VTT), a unique thought leadership platform that brings together leading minds, to discuss viral vector manufacturing facility design. The focus of the most recent VTT was on the current challenges and trends influencing design considerations for viral vector manufacturing facilities and how they can impact companies developing cell and gene therapies.

• Utilizing External Collaboration To Accelerate Vaccine Development

  Securing a partner to serve as an extension of Janssen’s Biotherapeutics Development API-Large Molecule team was essential to reduce both risk and the time needed for delivery of clinical supplies.

• The Hanor Family Of Companies: Companies Running Faster And Leaner With DocStar

  To enhance efficiencies companywide, Hanor went live with the DocStar Enterprise Content Management (ECM) system with advanced workflow, reporting, and intelligent data capture in March 2017. After more than two years of shopping around, the program was selected primarily for its ability to improve productivity through enhanced interdepartmental collaboration, as well as eliminate time-consuming manual processes.

• Leveraging Expertise To Exceed Immunotherapy Customer Goals

  A biologics company needed a CRO with a dedicated oncology team to manage its Phase I, multi-center study to evaluate the safety and pharmacokinetic (PK) profile of an immunotherapeutic drug in subjects with advanced solid tumors. They found a clinical trial partner with oncology experience that could support protocol design and accelerate the start-up process to meet a quick first-patient-in (FPI) milestone.

• ICH Q12 Updates: Increasing Efficiency Of Post-Approval Changes

  Through proper implementation of ICH Q12 tools and enablers, the industry could manage CMC changes effectively under a company’s pharma quality system with less need for oversight prior to implementation.

• How A Top CRO Used ClinCard To Create A Personalized Patient Experience For A Non-interventional Psoriasis Study

  The CRO realized that they needed to introduce new ways to keep participants engaged and interested if they were going to successfully support this trial. The CRO identified ClinCard as the ideal software that could instantly get study participants their stipends, without adding a burden on the site staff.

• Texas Cardiology Research Department Transforms Document Access, Fuels Productivity

  What drives an established and experienced clinical research site to completely transform the way they manage regulatory and trial documentation? For South Texas Cardiovascular Consultants, PLLC (STCC) it wasn’t just about paper, it was about what paper forced us to do.

• Large PMA Study Of CRC Diagnostic

  A study needed to enroll approximately 12,000 subjects and was also unique because it required subjects to self-collect samples at home. Read about the risk management and mitigation that Health Decisions utilized to keep the study on track.