From a management perspective, clinical trials are complex operations: they involve multiple stakeholders, who often need to coordinate their activities across countries and continents. At the cornerstone of this operation lies the need to develop an accurate budget from the very start.
Yet, while a trial is being conducted, circumstances and requirements change. In turn, these new demands are reflected as change orders issued to or by vendors, suppliers, or the CRO. These Change Orders (or COs) frequently make the trial – and its administrative burden – even more complex, and are likely to increase its final cost.
Having access to a realistic initial budget is crucial for Sponsors who wish to be able to address COs later on. It will be the basis for project control and will guide the allocation and utilisation of any available resources.
Budget development is, in many ways, a work of art. It often rests on two main pillars: deep knowledge of all necessary disciplines (which may involve medical, operational, and legal expertise)and efficient teamwork. Constant communication will occur between the CRO’s different business units, the Sponsor, and any external vendors and consultants.
Based on Dokumeds’ internal data, between 2017 and 2020, Sponsors initiated Change orders in 95% of cases.
It is noteworthy that two of the three most common reasons for change orders (those dealing with assumptions and scope) can be directly traced to the preparation done during the planning stage.
No budget can be 100% accurate, so it is practically impossible to eliminate the need for possible change orders later on. The considerations listed below may help decrease their likelihood and the degree of disruption they may cause to an ongoing study.
The responses and quotations received following an RFP constitute the backbone on which an initial budget is developed.
However, thorough and detailed RFP responses can only come from well-drafted and precise RFPs. When initially sending an RFP for a future clinical trial, the Sponsor should include as many specifications and details as possible. This is the first opportunity for the Sponsor and CRO to define the scope of their collaboration, so the CRO should not shy away from asking questions, requesting clarifications, and making their own suggestions. All of this may help the CRO better understand the Sponsor’s needs and strategy, as well as identify potential pain points and challenges.
In turn, the CRO will issue a series of RFPs to possible vendors and subcontractors. This is a great opportunity to test how efficient and transparent the established vendor management practices are in real life.
Dokumeds’ experience shows that most Change Orders are caused by having a vaguely defined initial project scope, or by a lack of clarity regarding the responsibilities, assumptions, timelines, and risks involved.
A good and simple tool for defining each party’s scope is to create a detailed task ownership matrix. This should list all tasks and responsible parties for each one. Whenever there is room for ambiguity, the CRO should be proactive and ask for any clarifications needed. By defining who is responsible for a specific process within a larger service, the correct party will be able to include it during their original budget estimate. This will prevent the need for a change order once the trial has already started.
At this stage, it is important to have access to experts who have specific experience on the trial’s geographical, therapeutic, regulatory, or other aspects. This way, both CRO and sponsor will be able to access realistic information about all the processes and approvals needed. For example, some countries may have special requirements for transporting IMPs, which can increase the cost of managing the supply chain.
The planning process for a clinical trial relies on a series of assumptions about the expected processes and requirements involved. To create the most accurate assumptions possible, the following information will be key:
Acquiring this information will, once again, require practical or first-hand experience in both study regions and protocol indication. Furthermore, the study budget should be transparent and understandable for all parties involved. This point will be particularly impactful when talking to a start-up or young biotech company with limited experience in conducting clinical trials
As real life shows, there will always be variables that cannot be fully predicted during the RFP stage. Appropriate risk-management practices will help face them with minimal disruption.
Some tactics that are worth considering include:
The strategies listed above may require, on a practical level, some adjustments to the way both Sponsors and CROs operate. Both parties should approach their relationship transparently and openly, and be willing to adjust to the other side’s preferences.
For Sponsors, it will also be necessary to provide ample time to develop a good RFP, and for potential vendors to respond to it. This will help ensure that the responses obtained are detailed and offer realistic numbers.
Meanwhile, the CRO should involve a diverse team of experts to assess each part of the RFP. These professionals should have both financial skills and knowledge of project procedures. This will not only help them develop accurate and realistic budgets but also evaluate risks and model different scenarios better.
Dokumeds’ background comprises over 25 years of clinical operations and local know-how across more than 30 countries covering several geographic regions. This ensures expertise in country-specific regulations, health care systems and other local competencies. Such knowledge and expertise can be of great significance whenever a Sponsor requires the development of an initial study budget, especially for multinational studies.
The Company’s experience in management tools and techniques, such as scenario-modelling, help Sponsors foresee and include out-of-scope costs. As a result, across Dokumeds’ trajectory, the company has only initiated 5% of change orders. This proves that our approach to feasibility, study and budget planning helps minimise the potential financial risk of conducting a clinical study.