While speed and efficiency are vital aspects of any study start-up, approaching the process with only these goals in mind can create issues that can set you back and impact the overall success of your studies. Fortunately, evaluating some of the details underlying your start-up timelines can remove the potential for certain missteps. With these things in mind, here are five tips for improving your study start-up timelines:
1. Have well-defined study start-up processes and workflows.
Research institutions should have standard study start-up workflows that can be used for every study. If workflow variation exists between departments, this should be documented clearly for everyone involved. Be sure to define who is responsible for each step, when approvals are needed, and which steps are done concurrently versus steps that are dependent on the completion of another task.
Without a defined process, study start-up can quickly become complex. There are many moving pieces that all need to tie together when the study opens. If each moving piece lacks appropriate tracking, you will spend all your time seeking out statuses and documents, rather than focusing on your study start-up role and growing the research program. You can also consider incentivizing staff to meet certain goals. This can drive collaboration between peers and departments.
2. Be clear about study-specific timeline goals with everyone involved in study start-up.
Make sure internal teams are aware of all goal dates. Don’t forget to let internal teams know that their deadline might be earlier than the overall deadline because their work is required to complete other start-up activities.
It is equally as important that external parties involved in study start-up are notified of your timeline goals and deadlines. When you send budget and contract edits to the sponsor, be clear about your goals. Sponsors and CROs appreciate a sense of urgency, and this can help to ensure your edits are reviewed quickly. Vendors need you to communicate your deadlines as well—they will not know your timeline goals unless you tell them!
3. Get to know the sponsors and CROs that you work with frequently.
Most sponsors and CROs are fairly consistent in their processes, and the items that they approve or do not approve tend to be relatively standardized. After a couple rounds of negotiation, reference previous budgets or contracts with the same sponsor. If certain items were never approved in the past, do not spend months trying to negotiate them. Additionally, if a CRO has a specific sponsor escalation process, have your documentation and other information required for the escalation ready when you first send the budget or contract to the CRO.
4. Consider outsourcing certain activities.
Know your institution’s capabilities and training. With certain activities, it is more efficient and less expensive to outsource than it is to hire a team to complete the work. For example, coverage analysis is frequently outsourced due to required level of training and complexity of Medicare rules. There are several companies that offer outsourced study start-up services such as PFS Clinical, BRANY, Kelly Willenberg and Associates, and Guidestar.
5. Make sure everyone in study start-up is fully trained and understands their role.
Lack of understanding is a common reason for study start-up activities to take longer than they should. It is crucial for study start-up staff members to not only know their role, but understand it may impact other study start-up activities. For example, if two separate people complete the coverage analysis and budget, both need an understanding of the other document and process. If the budgeter does not know how to interpret a coverage analysis, they could easily budget incorrectly, which can lead to double billing and other major compliance concerns.
Make sure the clinical team understands key administrative activities tied to start-up. While they are not usually responsible for these activities, they may need to sign-off on certain documents or may be consulted during document development. It is important for the study team staff to know what they are signing off on and why it is important for them to review the document quickly.
Just as study start-up lays the groundwork for your study, your approach to the start-up process can affect how smoothly your study will run. Incorporating these five tips into your study start-up procedures can help you improve your timelines and avoid frustrating delays.