Tech Challenges in the Phases of Life Sciences Organizations: the Clinical Trials Phase

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After the IPO phase, we get to the next phase’s tech challenges: life sciences clinical trials phase.

We know that your life sciences organization may go to the clinical trials phase before you go public with your IPO. Regardless, in terms of the tech challenges of this phase, it’s common to make clinical trials a highly manual process that organizations typically perform at the end of the month. It can typically take two to three days of a person’s time to manage this process, especially from a finance perspective.

With clinical trials come audit concerns. What also comes with that is a lot of communication regarding their trial both externally to the vendor and internally with the project manager. The manager needs to know what is going on with the project, how it is going, how complete it is, etc. With that, there’s a lot of collaboration between finance and the business. There’s typically approval processes in place, both in terms of purchasing and spending perspectives.

Lastly with the clinical trial phase comes the legal documentation. Before you can go sign off a large purchase order with a CRO, legal will get involved to ensure all of the right contracts are in place. This could lead towards integrating with third parties from managing that process.

Clinical Trials Phase Common Systems

Getting into some of the common systems that we’re seeing when managing clinical trials, we typically see file storage and document management growing more complex at this point. Changes and modifications to contracts are becoming relatively common as well. Many organizations bring in leading systems to supplement NetSuite, such as the likes of an Agiloft or a Conga system to really manage all the requirements that come with the legals, the sign-offs, the change orders, and all of the document management storage management and legal requirements around managing these.

However, we still see that the most manual process is the financial tracking of these clinical trials and the communication with vendors regarding the level of completion. Maybe communication is simple as asking have you issued us all of your invoices, but it may be more complex, asking for a status update on the trial. How far are you through it? What’s the level of completion? Life sciences organizations typically handle all of this communication, simple and complex, through Excel spreadsheets and emails.

Clinical Trials Solved

With clinical trials, we start to see shifts in roles and responsibilities. In the beginning phases, roles were traditionally more siloed. Now the clinical trials phase requires a higher level of collaboration across your functional teams. Scientists and operations need to see into budgeting. Finance relies upon the input of completion percentages and project changes from scientists and project managers. Of course, leadership has access to all of these contracts. It’s now vital that everyone has the ability to report on and view how the trials are going both from financial and operational standpoints.

life sciences clinical trials phase

This is where we are going to introduce Sikich Success for Life Sciences, and how it solves clinical trials within Netsuite. At its most simplistic form, we have a concept of a project or vendor study and your dimensional chart of accounts and purchasing processes. On top of that, we give organizations the ability to establish monthly project plans. Then on top of that, you can track what you truly incurred versus what the vendor is invoicing you. Last but not least, you have the ability to then automate month in journal entries as it relates to your prepaid or accrual stance on clinical trials. That’s important, because when an audit comes, the NetSuite system will be able to provide you with clear back-up into your prepaid in cool balance sheet accounts and positions.

After the clinical trials phase for life science organizations comes the big goal, the commercialization phase, which will be covered in the next post. Have any questions about the clinical trials phase? Please reach out to us at any time!


Other posts in this life sciences life cycle series:

This publication contains general information only and Sikich is not, by means of this publication, rendering accounting, business, financial, investment, legal, tax, or any other professional advice or services. This publication is not a substitute for such professional advice or services, nor should you use it as a basis for any decision, action or omission that may affect you or your business. Before making any decision, taking any action or omitting an action that may affect you or your business, you should consult a qualified professional advisor. You acknowledge that Sikich shall not be responsible for any loss sustained by you or any person who relies on this publication.

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