Sharepoint Solutions

WHITE PAPERS AND CASE STUDIES

• Method Development: Managing A Diverse Range Of APIs

  See how the team developed analytical methods to support pre-clinical and future GMP production under tight timelines.

• Small Molecule APIs: Aligning Drug Strategy With Partnering Strategy

  Development of novel small molecule APIs is increasingly turned over to outsourced partners who have become the primary drivers of the product’s overall development and go-to-market strategy. 

• Navigating The Latest ICH E8(R1) Guideline Revisions: Best Practices For Application With Increased Trial Variabilities

  This white paper highlights the key principles set forth in E8(R1), which was endorsed in May, 2019, and E6(R3), which is scheduled for publication in late 2022, illustrating how Sponsors and Contract Research Organizations (CROs) can achieve compliance. Cmed has been operating at the highest clinical research standards for over 20 years.

• Botanical Medicines In Research

  Botanicals have been used for millennia to combat illness—but why are there so few clinical trials testing the merits of this modality? This white paper describes rationale for why IRBs should embrace botanical medicine protocols.

• Vulnerability Management-as-a-Service: How To Improve Client IT Security And Your Profits At The Same Time

  This whitepaper was developed to serve as a blueprint to help MSPs create, sell, and deliver a profitable portfolio of vulnerability management services – a suite of offerings that are scaled and priced to meet the needs of every client, regardless of how small or how large.

• Navigating Regulatory And Development Milestones

  This article addresses how early-stage biotherapeutic companies can avoid common pitfalls as they navigate the funding and regulatory processes to bring novel therapeutics from research to market.

• Unified IRT And Clinical Supply Aligns Processes To Meet Timeline

  Partnering with a single vendor has been proven to significantly reduce errors, demand less time and resource from sponsors, deliver process automation to drive efficiency, and offer a holistic view of data that facilitates smart decision making and continuous improvement. Download Almac’s case study to find out how one sponsor was able to meet ambitious study milestones, thanks to the Almac ONE service.

• Accelerating Discovery With Improved IP Management - Streamlining Lab Execution With BIOVIA

  Inefficient lab workflows and poor visibility across research data was threatening to jeopardize clinical programs, from discovery to registration and beyond for a biotechnology company. They needed to replace their legacy, paper-based processes with an entirely digitalized lab environment that supported the innovation lifecycle from target identification to compound discovery and process development.

• Key Considerations For Selecting A Medical Pump

  Newcomers to medical device design may think pressure and flow rate are sufficient parameters to consider when selecting a pump. While this may be the case in some industrial applications, medical device requirements are more demanding and a thorough review of a medical pump's selection criteria is required to ensure the correct pump is chosen.

• Depositing - The Future Of Hard Candy

  Hard candy depositing is a process that has developed and grown rapidly over the last 20 years. Deposited hard candies and lollipops are now produced in every major confectionery market around the world by manufacturers ranging from regional specialists to major multi-nationals. This paper will review the basic principles of depositing and discuss the fundamental aspects of design that should be considered when engineering a complete depositing solution.

• Planned Emergency Research And Exception From Informed Consent

  This white paper focuses on key issues of interest to sponsors who may be interested in planning and designing EFIC studies, sites and investigators conducting EFIC research, and IRBs charged with reviewing EFIC studies.

• Removing The Barriers To eConsent Adoption

  eConsent technology has existed for nearly 20 years in various iterations. Read how sponsors have taken a cautious approach to using eConsent, piloting it on individual studies but refraining from incorporating it across all pipelines in clinical operations.