As if being solely responsible for the company’s medical innovation wasn’t a big enough job, today’s Life Sciences R&D professionals are hamstrung with inefficiencies and challenges such as collaborating with internal and external partners as well as centrally capturing, accessing, and integrating data for prospective decision making to name a few.
Most Life Sciences organizations have inadequate tools for capturing and acting upon attained “knowledge”.
- Meeting minutes in Word documents
- Spreadsheets with budget information and data points
- PowerPoint presentations to showcase progress and milestones
But all these elements are related by…what? Few companies have any framework to connect these objects or understand the relationships they imply. Various documents may showcase decisions and results, but they may not clearly show relationship between disparate information and how decisions were made.
In essence, Life Sciences organization do not have a clear path to learn from past experiences.
Without access to those insights, you risk having to explore similar fruitless paths in the future. You risk wasting time, money, and resources reinventing processes and procedures that you have already created. And not just once. Without tools that enable you to capture the knowledge, relationships, and the insights related to achieving those results, you risk wasting the same resources with every clinical trial you undertake.
The problem is a lack of institutional memory. Why did we make the decisions we did last time? Better question, what decisions did we even make last time?
The Clinical Trial Design Problem
Today’s clinical trial designs are strained with numerous deficits:
- 22% of data collected does not support any of the key objectives of the studies, and that percentage is even higher for the program as a whole.
- 1/3 of issues raised by authorities originate by program designs not generating supportive evidence 2
- Trial design is often based on “last experiences,” opinions, and trial-and-error
- Project Teams tend to be modeled on the basis of past design experience in a therapeutic area
- Inability to adopt “Best Practices of Design” by leveraging collaboration in the design process
- Inefficient means of capturing un-structured content to develop organic models for study design methodologies
In essence, there is no data, no history, and no verifiable information on how the decision was made . . . no Trial Design Memory.
In the absence of re-usable insights (institutional memory), organizations often waste time and resources planning and executing clinical trials as though conducting one for the first time.
What about Vendor Management?
Clinical Trials aren’t the only area Life Sciences organizations are lacking in institutional memory. We all know the significant savings or losses we incur when on-boarding vendor partners. Sponsors must effectively and efficiently manage and analyze a vast amount of information as part of the bid review process in order to identify the appropriate vendor/s to support the given clinical study program. However, traditional vendor proposal processes generate heterogeneous data that negatively impacts the Sponsor’s ability to conduct a true vendor comparative analysis from RFI/RFP inception through project/study conclusion.
As an industry, we’re still handling vendor management by hand with spreadsheets. The old ways aren’t only tedious and time consuming, they’re incredibly prone to error. Organizations should strive to realize specific and predictable outcomes in order to improve vendor analysis, insight, and management.
These outcomes should include, but are not limited to the ability to:
- Compare Apples to Apples: Compare the bid grids received from multiple vendor’s side-by-side in a streamlined manner
- Unify information on an integrated platform: Unified and integrated to better maintain, manage, and analyze the data
- Leverage Historical Data: For prospective decision making
- Support Error & Variance Check: In terms of resource model and price for a certain service support within the overall project
Okay, so what? We’ve been managing clinical trials and vendors this way for years…arguably decades. Is there really another option?
Well, at HighPoint, we think so!
These challenges are exactly why we developed the R&D Workbench powered by Salesforce.com. The R&D Workbench enables internal/external collaboration, process and content management, content sharing, traceability, and reporting in a fully integrated Cloud platform using SalesForce.com.
|WHAT IT DOES|
• Designed for use cases for rapidly changing processes, enabling effective collaboration, review and reporting from vast amounts of unstructured data in order to meet business needs
• Effectively enable global ways of working that support local and regional variances
• Facilitate collaborative data and information exchange (both internally and externally) to improve analysis, reviews and decision making
• Ability to understand and track how decisions are made to foster reusable methods and improve traceability
• Ability to interact with, influence and manage third party relationships across the organization
Tired of reinventing the wheel with every new R&D initiative? Download our R&D Workbench Webinar to learn about the benefits of institutional memory.
Are you prepared for upcoming IDMP data standard changes? Join us Wednesday, October 26 at 11:00 a.m. EST 4:00 p.m. CET for our IDMP Substances Webinar – a unique opportunity to collaborate with industry experts and peers.