By Katherine Feldman
Every clinical startup requires effective management of a discrete set of activities: the production of complete and compliant regulatory documents; efficient and comprehensive contract negotiation; accurate informed consent review; and timely institutional review board (IRB) submission and approval. In most large organizations, each of these functions is managed by a separate department within the company – each deploying its subject matter specialists in parallel, but not necessarily coordinated, paths. The regulatory specialist will reach out to a site to acquire its FDA 1572 form, financial disclosures, etc. Then a contract specialist will reach out to begin the process of contract negotiation, and a third person may be involved for IRB submission and informed consent form (ICF) review. Add to that a clinical manager working with the principal investigator to set up protocol training and the study kickoff meeting. All in all, close to a half-dozen people coordinate with the site, and that team most likely only touches base weekly. This is what is referred to in this article as functional specialization.
Gold standard, right? It’s lean. It’s specialized. Most would agree that it ensures that high-quality documentation and best practices are observed. Specialists collect their data and manage their processes. Many clinical sites employ a similar functional specialization.
In essence, clinical study startup consists of two organizations, the sponsor and the clinical site, and their respective departments, all engaged in internal parallel play. It can be like watching two octopuses try to shake all eight hands at once.
So, who manages the clinical trial? On the sponsor’s side, it is the trial leader, and on the site’s, it is the principal investigator. They focus on the protocol and the clinical logic of the trial and rely on the functional specialists to get their jobs done. Things go wrong. Human factors like ego and politics can confuse issues, but more important is the bureaucratic inefficiency that results from clashes in organizational cultures between the sponsor and clinical site. Only rarely do substantial issues of content in a contract, IRB submission, and/or regulatory documentation require the specialized knowledge functional departments bring.
If most delays are caused by the complications of aligning two organizational cultures, then someone must take a deep dive into their organizational culture and create a supportive process that encourages focus, harmony, and results. A single point of contact (SPoC) is a role that encompasses all the nonclinical responsibilities of study startup. The SPoC interacts with functional specialist on both sides and assures that technical issues get proper consideration, sparing the specialists from the 90 percent of the issues that are caused by organizational and human friction. This role initiates the study startup process and is accountable for regulatory document collection and review and for contract negotiation. It ensures that a clinical site is document ready for the shipment of clinical product to the site. A SPoC has visibility of the entire process and can take the deep dive into the organizational culture of a clinical site to help focus the process, remove obstacles, and problem solve in real time to create efficiencies benefiting both the clinical site and sponsor.
Sponsors may be, in essence, purchasing services from the clinical site and consider themselves customers because they are paying the bill. Make no mistake, though, the clinical site and its staff are also the sponsor’s customer. Sponsors need to understand them as customers and treat them like customers. Sponsors need them now and need them back.
In the business of clinical study startup, a SPoC, for all aspects of nonclinical management, has shown to be more successful in yielding significant benefits in both time and money.1 It reaps the advantages of relationship building, risk mitigation, and communication from a customer relations standpoint.
Why does it work? The SPoC taps into three foundations of good customer relations:
1. The Power of "Yes"
The SPoC is accountable for all documentation and, ultimately, ensuring the site is document ready to be opened. This accountability encourages the SPoC to have a “get to yes” mind-set. They are empowered as the frontline people to work with their customers the way the customer wants to be served. They must find ways to work with the site, as they can’t pass the buck to another team. They are invested in the opening, rather than just getting the documentation for their single function.
For example, a certain institution has a chiseled-in-stone policy that contract negotiation will not begin until its IRB has approved the protocol. The SPoC tasked with opening this site knew that her company needed that site to open just about when the IRB was expected to complete its review. There would not be enough time left to negotiate the contract. What to do? By building a relationship with the site staff and being curious about the process and policy behind the process, the SPoC asked the right questions and found a way around the policy.
2. Identify and Anticipate Needs of the Customer
The more you know your customers, the better you become at anticipating their needs. A SPoC’s closeness with the site makes them naturally more aware of potential roadblocks or areas of risk to timelines. They listen to the customer, partner with them, and take responsibility for the communication flow. With a carefully constructed project management tool, the horizon of the entire process is visible, enabling them to identify and anticipate the needs of the customer and mitigate potential risks to study startup timelines.
With functional specialization, it’s not always clear who is responsible to anticipate and prepare for common risks. For example, what do you do when the principal investigator goes on vacation in the process of study startup? When separate functions are all going about their document collection, that piece of information, if conveyed, may not be passed to someone who can keep it from costing time and money. The SPoC utilizes this information to change the horizon of the project by working with the clinical site staff to mitigate this risk.
3. Make Customers Feel Important and Appreciated
Clinical site staff are sensitive about who really cares about them and their patients. Train every SPoC to appreciate each of their customers differently and challenge them to find the way each customer likes to be recognized. Some may value your appreciation of their scientific contribution, uniqueness of their practice, commitment to their patients, or the prestige of the organization they represent. It’s not about creating a VIP experience; it’s about communicating partnership and that they can trust that the SPoC will help and is as dedicated to their success as she is to her company’s.
This is best exemplified by a study in which a network of sites was selected to participate. Each site was a separate legal entity, and each had to be started individually. Halfway through the process to open the first site, the site staff was so pleased with how easy it was to work with the SPoC, they volunteered to coordinate startup of all the sites within the network. This significantly reduced the time and effort to start all of the sites.
Clinical study startup is not rocket science, but it is perceived to be a complicated and demanding process. Even with the most complicated protocol, unique treatment, or challenging patient population, a majority of clinical study startup is wash, rinse, and repeat. Substantial issues of content in contracts, informed consents, or regulatory documentation is the exception. More expertise will not remedy the fact that much of the time in study startup is spent waiting for bureaucratic inefficiencies to work themselves out. A SPoC who manages the customer relationship, skillfully mitigates risk, and takes full responsibility for documents ensures a great customer experience for clinical study sites.
About The Author:
Katherine Feldman has 20 years’ experience in contract research organization and big pharma environments. She is credited with delivering high-impact innovations in the clinical operations management space. Her teams have been credited with the introduction of novel processes that reduce costs and timelines to improve efficiencies.