Business Process Outsourcing

WHITE PAPERS AND CASE STUDIES

• A Site Network’s Experience With eSource Before And During COVID

  Discover how the world's leading vaccine network adopted eSource during COVID-19 despite many obstacles that got in their way.

• UW Carbone Cancer Center Gains Visibility Into Site Accrual

  Monitoring accrual is a key responsibility for a cancer center administrator. From answering questions for leadership to preparing for a grant submission, knowing the ins and outs of a site’s accrual metrics can ensure greater operational efficiencies center-wide. Read how UWCCC was able to enhance their data analytics and visualization capabilities helping them improve operational oversight, especially through greater visibility into site accrual metrics.

• Mitigating COVID-19 Risks In A Complex, Fast-Moving Pain Program

  A cutting-edge biotech was running a program with three active, concurrent, pain studies across 25 sites and 218 patients, with interim database locks scheduled during the summer of 2020 and final database lock deadlines looming close behind. The COVID-19 pandemic put that all on the line.

• Leveraging A Central IRB Office To Improve Turnaround Times And Consistency

  With over 100 sites in the Academic and Community Center Research United (ACCRU) research network, utilizing a central IRB office was essential to increase review consistency and turnaround times.

• Outsourcing Trusted-Weight Dry Powder Chemicals To Support Expansion

  The gene therapy division of a major pharmaceutical manufacturer was looking for ways to overcome capacity constraints due to the increased production demands for process liquids and buffers. Non-core manufacturing activities, including the weigh and dispense steps in the process liquid and buffer preparation, were identified as bottlenecks impacting the overall production schedule. The proposed solution would provide ready-to-hydrate, trustedweight dry powder chemicals. Read how the customer benefited from the procurement of larger lot sizes that were not capable of being handled within their facility, resulting in annual savings for raw materials and QC testing.

• The Largest Parkinson’s Disease Study Ever Attempted Is Being Made Possible Only With Mobile Research Nurses

  The Trial of Parkinson’s and Zoledronic acid (TOPAZ) is seeking to enroll 3,500 participants over the age of 60, making it the largest double-blind, placebo-controlled, randomized clinical trial ever attempted in people with parkinsonism. Find out the approaches taken and the results in this case study.

• How To Avoid Last Minute CMC Roadblocks To Approval

  Problems can arise when sponsors face balancing available budget and time resources between clinical and chemistry, manufacturing, and controls (CMC) needs. Because of their high-profile importance in development, clinical needs get the emphasis, while the many CMC needs and risks may seem less critical. This is a brief overview of the CMC information required by regulatory authorities and highlights why planning and budgeting for key CMC considerations early in the development process are essential for success.

• The Case Of The Elusive Protocol

  A client required a chart review to evaluate survivability of pediatric patients with a rare metabolic bone disorder. By trying different protocols and overcoming complex issues of informed consent that had to be resolved before the study was successfully completed, they were able to successfully deliver a final clinical study.

• Choose A CDMO Partner That Integrates Market Intelligence For Aseptic Fill And Finish

  To offer customers both favorable outcomes and exceptional value, a CDMO must make the curation and integration of deep market intelligence a core part of its service offering. 

• City Of Burnaby Pivots Parks GIS Team During COVID-19 Response

  Fifteen minutes southeast of Vancouver, Canada, the suburban City of Burnaby is known for its rich trail systems and forested conservation areas. In a city of over 235,000, Burnaby has over 160 parks and trail systems.

• Process Engineering And Industrial Modeling Collaboration Delivers Improved Efficiency And Facility Throughput

  Utilizing a wide range of expertise, IPS team members interfaced with MilliporeSigma’s operational group to design new layouts and processes that would optimize the facility’s flow and throughput.

• Using Software Systems To Drive A Successful CPV Program

  An area of life sciences that has recently received significant attention around data, its integrity, and its management processes, is manufacturing. This article covers bio/pharma manufacturing process information management systems, with insights on how purpose-built systems incorporated into your continued process verification (CPV) program helps meet FDA requirements and protect your business.