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In this resource
Strengthen your processes and increase data-driven decision-making for faster study start-ups.
Strengthen your processes and increase data-driven decision-making for faster study start-ups.
When writing this blog my mind instantly turned back to my outsourcing days at Biomarin. Like many mid and large Sponsors, we were using the company templates for contracting with clinical service providers. Creating new documents such as statements of work (SOWs) and Change Orders (COs) for CROs, labs, technology vendors. The process was like this:
- A contracting or outsourcing specialist was assigned to generating the contracting document.
- The starting point was the awarded proposal from the service provider, which sometimes was a Word document, but most of the time, a PDF.
- The company approved template had several “open” blocks that had to be completed by the contracting specialist. These ranged from start and end date of the service, to service description, summary budget (broken down by several categories) and payment schedule.
- The specialist would look for the required information in the awarded proposal and either 1) cut and paste the required information or 2) look for the relevant information and re-write it in the required fields of the template.
- Sometimes, the service provider participated in the process. The specialist would send the SOW template and ask the provider to fill in the blanks; however, QC was always required, especially after a few negative experiences.
- Regardless of the approach, the proposal (or summary pages, if the proposal was too lengthy) was included as an Appendix.
- The completed document would go for quick review (usually by the Head of the department, which happened to be me in this case) and then sent to legal for final review and signatures.
Overall, the process took easily a day by the specialist and a few weeks for the review and completion.
Of course, the process could be faster, if it weren’t for the queue of documents that was piling on each specialist desk and mine; in between, various stakeholders kept asking for the status and the service providers as well, wanting to know when the contracts would be executed.
Add to this the end-of-quarter (or end-of year) pressure on outsourcing and legal and the genuine desire to “get the work done” and you can imagine how busy my team was and why. This is part of what drove me to create Clinical Maestro.
With the launch of Clinical Maestro, I temporarily forgot about this recurring pain point that caused so much stress to so many stakeholders within my organization. However, soon enough I started to feel the pain from the service provider standpoint.
Why isn’t the SOW executed? What’s holding it up? As a start-up, getting thecontracts signed is super important for the investors, morale of the employees, and the Board.
But in pharma contracting bottlenecks cause extraordinarily long delays, which many see as avoidable. Publicly traded service providers, who reported backlog and commitments quarterly, are even more severely impacted. The stress is all high: pressure on small outsourcing teams, pressure on the service providers, everybody is hurting
Just as I was trying to wrap my head around it, in a team meeting, one of our strategic partners brought up the concept of automating the generation of contracting documents. We immediately related to this pain point and recognized their point as a strategic initiative to eliminate the delay by leveraging technology. Why couldn’t Clinical Maestro solve this problem? You already have the sourcing software all the way to the award. The missing piece was setting up the templates in a way that eliminated the “cut and paste”, reduced the review time, and answered to various stakeholders, both internal and external.
In 2021 we decided to embark on the journey of building the industry’s most advanced engine for contracting documents generation. What started as a spark from an innovative Sponsor was reconfirmed by multiple other Sponsors, from small biotechs to top pharma. Generating contracting documents is a royal pain point andyes, it is avoidable, if we put technology at work.
The result? A totally new approach backed by latest technology that incorporates “smart fields look up” in the proposal documents to dynamically populate the “open spaces” in the Sponsors’ contracting template, bringing >90% productivity in document generation and review.
What’s even better? Internal stakeholders who benefit from role-based access, can simply log in and view the contracting documents, saving time in writing inquiry emails and adding even greater workload to the sourcing team
I love that many of the ideas for new features for Clinical Maestro come from our customers and industry experts, whom we engage regularly either through Product Steering Committees or our annual User Forum event. We are an idea lab and seeing that the industry is hungry to participate and contribute, which means, more blogs to write and more features to come
In this resource
Strengthen your processes and increase data-driven decision-making for faster study start-ups.
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