Starting a clinical research site is an exciting opportunity for the ambitious research professional looking to progress from employee to site ownership, or the medical entrepreneur looking to expand a portfolio with a lucrative investment. Clinical research provides financial and altruistic appeal: a successful site will conduct a diversity of studies with commensurate compensation. The data generated (from trials conducted) could possibly contribute to a regulatory agency submission for new drug approval. At the very least, a successful site will impact the drug development process.
Beyond the altruism is the enormity of work involved in establishing an investigative site. From funding to infrastructure, staffing to strategic connections, it takes business and clinical acumen to start and a salesperson’s mentality to sustain a successful study site.
Appropriate funding is integral to starting and continuing the site momentum until new trials can sustain the effort. The investigational site founders must know the amount needed to start the site, and how long the funding will cover all costs until xxx deadline and the need to re-fund or re-evaluate the effort.
Some prospective site owners self-fund-with personal savings or business loans, while others align with investors or physician groups looking to expand into clinical research. Gualberto Perez MD, founder and president at Research GCP, and a successful research site owner, has participated in several successful financial strategies for site start up. Perez states that "it all depends on the size of your start up. When I first started many years ago (25 approximately) we commenced in a big way with a full-blown phase I unit— multiple private investors; we later borrowed from a bank”.
Ten years later Perez opened his late-phase site GCP Research with his own funding. He grew it organically in a financially graded fashion, expanding to other services and embarking into outpatient phase I work. His success is due to his expertise, and the incredible work ethic needed to start an investigational site.
The right location is dependent on the site model and overall objective. An ambitious early phase site may need a larger facility to accommodate specific serial testing (blood, respiratory, vitals) and visit duration (overnight and or extended patient stays), while a medical office/clinic would accommodate the needs of an investigational site conducting simpler late-phase trials. The basic location requirements are examination room/bed, locked area for refrigerated or ambient study drug storage, secure storage for supplies/records, staff and monitor work areas, a room for specific activities (if needed) such as blood draws/electrocardiogram/pulmonary function testing and a lab area for blood/urine processing, (centrifuges) storage/shipment (freezers). There are additional lab certificate/waiver requirements dependent on the type and extent of lab testing to be completed at the site.
Establishing infrastructure with standardised clinical research process (informed consent, safety reporting, deviation reporting, study drug administration/destruction, staff on boarding and training, etc.) and staff job descriptions will promote consistency and transparency with job performance. Centralised filing of staff licensure and training certificates (for such things as good clinical practice, equipment, and computer systems/study devices) to correspond with the delegation of authority log demonstrates due diligence and appropriate task delegation.
Patient recruitment is integral to successful study conduct and sponsor consideration for repeat business. For a dedicated research site, affiliation with hospitals, clinics and/or physician practices is critical to identify and enroll patients, as well as recruitment staff to develop tools/tactics to advertise the studies. Alternatively, some investigators house the research department within their physical medical practice and may have the opportunity to review their practice database for potential patients.
The ideal functional team includes the experienced physician investigator, study nurse/coordinator/data manager (to divide clinical and administrative, scheduling and data management duties), experienced finance/legal/business personnel to handle contracts, budgets, and business strategy to optimise site growth, and key individuals with the network/relationships to attract investigational studies.
Role is also driven by site size and business model. A study coordinator at a smaller physician practice will likely wear many hats and complete study duties as well as contracts, regulatory and recruitment. A larger research site will have separate personnel for clinical, data management, legal and administrative responsibilities, as well as dedicated business development staff to cultivate relationships.
The smart administrator or investigator will develop connections with local imaging, ophthalmology, spirometry, e.g. medical offices that perform ancillary testing, so that if a study presents with specific safety testing requirements for study drug, the ancillary facilities are already vetted and capabilities confirmed. This strengthens a site’s credibility and helps diversity their therapeutic portfolio.
Dan Sfera, CEO of DSCS CRO and “The Clinical Trials Guru” podcast host, as well as a successful investigative site owner, feels that adaptability and salesmanship are two critical traits for successful site owners. Sfera says that the effort should not be underestimated when starting an investigational site.
“If there are any important lessons that I’ve learned to own a clinical research site, it is the fact that there are almost no rules or guidelines or standards for how to structure your business. When starting out, it could be very challenging and overwhelming for somebody coming from a structured environment, such as a CRA or a study coordinator, to go out on his/her own and become a site owner. At the end of the day, the most important concept that you need to understand and master is the art of salesmanship. You must understand that from the very minute you start your site as a business owner, you are a sales person first. It does not matter what your background is. It does not matter what you’ve done in the past. You have to master sales.”
Sfera also gives two pivotal examples of adaptability as a site owner; “the ability to adapt. I talk about this all the time. Your first principal investigator will probably leave you at some point. The studies that you specialise in at some point will go through a downcycle. The patients that used to get referred to you will at some point stop. The same thing goes for your employee’s retention.”
Whatever the motivation, or business model pursued, an individual with the tenacity, experience and work ethic has the potential to build a successful research site that will benefit society and the employees vested to make it successful.