Sharepoint Solutions

WHITE PAPERS AND CASE STUDIES

• Rescuing A Global Program For NDA Success

  Explore the collaboration that enabled FDA approval of a novel chronic-condition therapy, rescued a high-risk program, and demonstrated a unified “one-team” approach by reworking the sponsor's SAP.

• Early-Stage Development In Rare Pediatric Oncology

  Learn about the strategic approach a biotechnology company utilized to address significant hurdles in launching a Phase 1 clinical trial for a novel therapy targeting a rare pediatric cancer.

• CRO Leverages Integrated Central IBC Partnership To Initiate Sites

  Learn how a CRO was able to accelerate review times so COVID-19 vaccine trial sites could progress through site selection, IRB/IBC submission, approval, drug shipment, and complete site initiation visits in record time.

• Case Study: Recruiting Pediatric Ultra-Rare Disease Patients

  Explore how Rezolute was able to overcome challenges while recruiting pediatric patients for a Congenital Hyperinsulinism (HI) clinical trial using a streamlined, single-source tool.

• Increasing Batch Size And Reducing Cycle Times For A Biologic

  JHS partnered with a global pharma company to optimize biologic production, increasing output by 50% and reducing batch release times by up to 30%.

• How We Used Intelligent Automation to Transform Vendor Selection

  Discover how your small biotech can achieve faster timelines, improved cost control, and more strategic, transparent choices with a platform leveraging intelligent automation.

• Disclosure Management System: Build Or Buy?

  Clinical trial disclosure regulations are tightening worldwide. In order to maintain compliance, sponsors must determine whether to build an internal disclosure management system or buy a solution.

• Patient-Focused Data Capture For Cancer Research

  In a field where innovation is constant and patient experience is pivotal, oncology demands eCOA solutions designed to balance scientific rigor with human realities.

• What Does The New FDA DHT Guidance Mean?

  In December 2023, the FDA released the final version of its digital health technologies guidance, outlining the facilitated use of sensor-based DHTs and wearables in clinical investigations.

• The Digital Transformation Of A Leading CDMO's Process Development Lab

  Discover how a leading CDMO was able to create a data model for its bioreactors, resulting in easily contextualized data, time savings in manual tasks, and the ability to share insights in real time.

• Cleanroom Recovery. Proven Results. Contamination Control Case Studies

  Through this collection, review how a proven, automated solution can help facilities stay compliant, operational, and protected — whether in a crisis or during planned maintenance.

• A Strategic Guide For Biotech And Biopharma Leaders

  Securing drug approval is a complex, high-stakes process, and outdated review workflows hinder progress. Explore modern solutions that accelerate timelines without compromising compliance or quality.