Each contract should understand the power of communication with their partners or providers to avoid encountering defects in their clinical trial contracts.
Fremont, CA: Clinical research organizations (CRO) play an essential role in the drug development process, where these organizations depend on pharmaceutical manufacturers to lead trials. In any contract negotiation between two organizations, there are certain fundamental things to be set up. There should be expectations and agreements across two organizations while being transparent and providing all necessary details on the deliverables. Of all, they should engage in an honest relationship. Here are few necessities to make an effective CRO.
Before laying grounds for a project, consider the contracting timeline in the planning phase. If the provider does not have any previous or master services agreement, then the contracting process will become a time-consuming process, as it needs a more complex contract type. It will require communication between the legal departments. Once the provider is chosen, ventures should immediately get associated with the contract manager. Although, exchanging contract drafts is essential, outlining limitations with funding or term is the second important thing as it can build trusting relationships with providers.
Understanding the intricacy of the contracting process
Contracting is not a direct process. Develop realistic and best-in-class contract development timeline through the following steps. Firstly, plan 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 multiple rounds of analysis are required, then stop and examine the purposes for various interpretations. Finally, build in time for the last review and signatory process that vary by organization. Some require the signature of a higher authority who might be hard to get to and checking the availability of signatory, in case of emergency, notify them in advance without postponing the contracting process.
After the effective culmination of the contract development timeline and planning, a discussion should be made for specifications driving the financial backing, review the budget, and build the contract. Spending hours to create a budgeting tool and populating a deal is worth a lot. These specification files can then be exchanged via online platforms and caught up with a meeting to finalize.
In every contracting process, transparency is vital. The budget format varies between each 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. Particularly when a CRO is against 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 far in the contract by minimizing misunderstandings.
Pay close attention to the degree 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 quantity, and the analyst should review the unit as well as the complete expense.
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 teams on both sides consistently apply the checklists. The real outcome is when one enforces the utilization of the checklist because there is no point in simply setting the expectations.
Of all, always follow through the responsibilities, including timelines, and keep in close communication with the partners. Keep 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.