Each sponsor and study will have slightly different needs, but there are common minimum standards an AIC will need to meet before being able to productively discuss participating in research with a potential sponsor or CRO.
Broadly, the requirements break down into research personnel, organizational capacities, and physical capacities.
Any clinical trial will by necessity require that the researcher at each site is a physician with a medical license, because the clinical trial involves delivering clinical care. Few AICs will stumble here, for obvious reasons. What complicates this question for many AICs is that researchers will need to be able to demonstrate a background in conducting research—if your company is new to research, it’s likely that your physician or physicians on staff will be at least somewhat removed from their research days if they even have any experience in the area at all.
To overcome this obstacle, the simplest (but most expensive) solution is probably to hire an established principal investigator with significant research experience. Bringing on a dedicated hire will derisk the company’s participation for sponsors significantly, and will likely also help the company do a savvy job of efficiently and effectively adapting some or all of its locations for research, especially from a staffing and training perspective.
If an AIC would rather get into the research game with the staff it already has, the next best approach to derisking its principal investigator is to have them contribute to studies under different sites as a sub-investigator first, which will give them research experience without requiring the company to land studies. Another option is to have them participate in simpler and less protocol-intensive phase three and phase four studies to gain experience first.
Beyond research experience, studies and their IRBs will want to be able to prove that the researcher has relevant experience in the treatment area and subject matter that the trial is studying. Lastly, they’ll need to demonstrably understand trial conduct, which means they should invest some time in collecting proof of training (like GCP) to show that they’ve learned the ins and outs of the process.
In addition to a researcher, many AICs will find it helpful to bring on a clinical research coordinator (CRC) with trial experience to help with the administrative aspects of conducting research. A new hire who comes equipped with a CRC certification from the Association of Clinical Trial Professionals could bring valuable wisdom and experience to the team as the company stands up a research arm of the business.
From a physical perspective, AICs will have less delta to resolve than some other prospective sites might. The most important physical requirements are storage capacity and appropriate facilities for both the clinical care aspect of the study and the informed consent process, like a non-threatening, non-clinical meeting room where researchers and staff can speak to patients. The site’s first storage need is for supplies, notably the size and type of fridges appropriate to the investigational drug as well as the study kits the sponsor or CRO will send to each location. The second is for the secure storage of data, both electronic and physical, during the trial and for however long after the trial the data needs to be preserved.
The site will also need to equip itself organizationally. One organizational requirement is the establishment of standard operating procedures (SOPs) for common components of study protocols, data handling, documentation of protocol deviations, reporting for adverse and serious adverse events, and hosting monitoring visits.
The other is staff training: aside from GCP, staff will need to be able to follow those SOPs exactly, even for tasks that are rarely part of the day-to-day for AIC clinical staff, and log and enter data into new-to-them systems according to the needs of the study. Some of these training requirements will also affect the site’s administrative staff. This isn’t just extra work—especially for interested staff members, there are educational opportunities and work experience that can unlock additional career paths within the world of clinical research, so they get some upside out of it, too.
Lastly, most AICs will need to identify and reach out to provider partners that can handle those requirements of study protocols that aren’t in scope for the AIC’s abilities or equipment, like imaging or lab work. Since steps obviously vary by study, most AICs will want to cover the basics at first and expand their network over time as necessary. The ability to accurately factor in the cost of sharing standard-of-care study protocol steps with outside providers will be an important factor in being able to protect margin in study budgets, so this step bears some consideration and real effort.
We will cover the process of negotiating adequate budget for the cost of care provided by partners in chapter 6.
Sponsors and CROs prefer sites that distinguish themselves in three key ways: they are easy to work with, they conduct studies accurately and on time, and they are able to recruit patients. All three of these factors are easier to prove over time than beforehand, so sponsor-site relationships tend to evolve, but there are ways a new entrant can signal all three when pitching sponsors.
To be easy to work with, a site has to have a clear process for navigating the initial phases of the engagement. Being prepared to meet the requirements in the previous section is part of being easy to work with. Another important factor is having a deep understanding of the line-by-line costs each location needs to cover with the trial budget before entering into negotiations with the sponsor. For a business that is new to clinical research, being able to speak confidently to all of these factors in early pitches can help sponsors understand that the site is serious and sophisticated in its approach, rather than just dabbling.
Completing studies by the book and on time or ahead of time will be more difficult for an AIC to demonstrate before it has any history of doing so, but a group that brings on dedicated personnel from the research industry will be able to use their CVs to its advantage.
But the real distinguishing factor an AIC can bring to the table in early conversation with sponsors is access to a unique patient population.
Studies worldwide and across areas of interest struggle with patient recruitment—it’s probably the most painful topic in the clinical research space (aside from budget). Recruitment is a function of patient populations and strategy, but the strategy is useless without the patients to recruit from.
Sponsors are developing drugs for patients in very specific circumstances. To narrow down the variables that would complicate their ability to demonstrate a specific effect within specific constraints, they develop study protocols that have exact requirements for the patients that can enroll. These requirements are a dual set of inclusion criteria (traits that the patient must exhibit) and exclusion criteria (traits that mean that the patient cannot participate). The inclusion criteria predictably include a diagnosis or condition, and so sponsors will firstly be looking for independent site partners who offer treatment to patients with that indication. For AICs, which work extensively with patients who have conditions treatable by recent drug innovations by nature, the likelihood that their patient populations exhibit traits of interest to current pharma research is quite high.
Another key differentiator that AICs can highlight against large research institutions or hospitals is the geographic access they can provide. Because institutions tend to be concentrated in larger urban areas, and because many (especially multi-year) studies involve the expectation of frequent touchpoints or long-running relationships, research conducted in those institutions can have trouble enticing patients to participate, even when they offer to pay for travel costs. AICs are by nature distributed across wider areas, and therefore can offer sponsors access to harder-to-reach patient populations. Research has demonstrated that many sponsors (75% in this survey across Nordic companies) are open to working with less experienced sites just for their patient populations, so AICs’ access is a real differentiator.
In addition to patient populations that are simply net new to sponsors, AICs may serve different demographics from research institutions and hospitals. Study sponsors and researchers often want to include patients from a variety of genetic and social backgrounds in trials because of a desire to fully understand the effects of the investigational drug across broad populations. Researchers generally struggle to enroll patients in minority groups (for a variety of reasons, including historical), so AICs who can say their patient populations include those groups will have another advantage here.
Lastly, AICs can lean on their expertise in marketing and advertising. Researchers have limited toolkits for making target populations aware of the studies they’re attempting to recruit, but AICs often have greater and more direct experience with go-to-market tools and practices that can enhance their appeal for sponsors.