How to Make Sure CRO Becomes "A Great Success"?

How to Make Sure CRO Becomes "A Great Success"?

By Pharma Tech Outlook | Wednesday, November 13, 2019

Each contract organization should embrace the power of communication with their partners or providers so that they will never encounter flaws in their clinical trial contracts.

Fremont, CA: Clinical research organizations (CRO) play a vital role in the drug development process, where these organizations rely on pharmaceutical manufacturers to conduct trials. In any contract negotiation between two organizations, there are certain basic things to be set in place. There should be expectations and agreements across two organizations while being transparent and providing all necessary details on the deliverables. On top of that, they should engage in an honest relationship. Here are some necessities to make a successful CRO.

Right Planning

Before laying grounds for a project, think about the contracting timeline in the planning phase. If the provider does not have any previous or master services agreement, then the contracting process will take a longer time, as it needs a more complex contract type. It will require interaction between the legal departments. Once the provider is selected, enterprises must immediately get connected with the contract manager. Although, exchanging contract drafts is vital, outlining limitations with funding or term is the second crucial thing as it can build trusting relationships with providers.

Understanding the complexity of the contracting process

Contracting is not a straightforward process. Develop realistic and best-in-class contract development timeline by acquiring the following steps. Firstly, schedule the date of the kickoff meeting about what needs to be done before signing a contract. One round of review is advisable. However, two rounds will serve better. If more than two rounds of analysis are required, then halt and examine the reasons for multiple analyses. Finally, build in time for the final review and signatory process that vary by company. Some require the signature of a higher authority who may be difficult to access and checking the availability of signatory, in case of emergency, notify them in advance without delaying the contracting process.

Setting alignment on budget specifications

After the successful completion of the contract development timeline and planning, a discussion should be made for specifications driving the budget, review the budget, and build the contract. Spending hours to create a budgeting tool and populating a contract is worth a lot. These specification files can then be exchanged via online platforms and followed up with a meeting to finalize.

Enabling transparency

In every contracting process, transparency is critical. The budget format varies between every contract, and every CRO has a specific budgeting tool. Individual proprietary tools can create challenges in the relationship between the sponsor and the CRO. Disconnection originating from the lack of understanding of the specifications hinders transparency. Especially when a CRO does not agree on specifications from the sponsor, the process becomes more complicated. A CRO must think about all the specifications underlying the budget and driving the cost, and these small considerations can take a long way in the contract by minimizing frustration.

Pay close attention to the level of specificity in the budget, as they are unique, where every contract reviewer has a different level of experience and expertise. For every budget activity, it shows the unit type and the number of units and the reviewer should review the unit as well as the total cost.

Building quality standards

Build quality standards into the reviewing process before exchanging budgets and contracts. However, to achieve the quality standard, create a tool such as a quality checklist and develop processes that assure that the checklists are consistently used for teams on both sides. The real outcome is when one enforces the use of the checklist because there is no point in merely setting the expectations.

Of all, always follow through the commitments, including timelines, and keep in close communication with the partners. Embrace keeping in track of the contract deliverables at all levels. Investing in professional relationships with the sponsor organization will create more opportunities to know about each other.

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