Greg Orzeck Looks at How to Start and Sustain a Reputable Clinical Research Organization
Before a new drug or medical product is introduced to the market, it must undergo multiple clinical trials involving animals and humans in order to verify efficacy, ensure safety, and identify all potential side effects and contraindications. That is where Clinical Research Organizations (CROs) play a pivotal role on the consumer healthcare landscape.
According to Greg Orzeck, the co-founder of AI Research Inc. which has over 20 years of experience providing expert clinical monitoring services across the U.S. and Canada, here are the key elements of starting and sustaining a reputable Clinical Research Organization:
Conduct Market Research and Select a Niche
Research by procurement intelligence and supplier compliance solution provider Beroe estimates that the global Clinical Research Organization market is growing at a compound annual growth rate (CAGR) of 6.9 percent and is on pace to hit $41 billion (USD) in total annual revenues by the end of 2019. To tap into this growth and avoid getting crowded out by more established and richer competitors, new Clinical Research Organizations that want to make a name for themselves should consider targeting niches such as new pharmaceuticals, medical devices, dental devices, and nutriceuticals.
Greg Orzeck states that some start-ups in the Clinical Research Organization space end up spreading themselves too thin; not necessarily to maximize profits right out of the gate, but to mitigate risks. While there is some sense in this approach, generally speaking it is wise to initially focus on a single niche at first and look at opportunities where the profits may not be high enough to attract and interest larger competitors. Once a Clinical Research Organization builds a solid reputation and establishes credibility, they can strategically expand their scope of services based on their competencies, competitive advantages, staffing roster, and prevailing marketplace dynamics and growth opportunities. For example, AI Research Inc. has evolved over the years and now provides comprehensive on-site and remote monitoring, as well as end-to-end clinical trial execution solutions, and prides itself on having an all-RN and medically trained staff.
Build an Impressive Team
A new CRO will thrive, or struggle based on the strength and talent (or lack thereof) of its roster. Hiring qualified staff is especially important since the business plan — which will be used to forge relationships with clients, investors, and other strategic partners — will need to highlight the qualifications of key personnel who will supervise the research.
Orzeck reiterates that “at AI Research Inc., all of the staff are Registered Nurses, which allows us to function well in hospital settings when carrying out clinical trial monitoring and training hospital staff.”
A major factor in the screening and onboarding process is attention to detail. It is crucial to carefully screen applicants using a variety of tools including web-based interviews, professional references, and a range of technical and personality-based phone screens based on the role. Once onboarded, verifications, including employment and background checks, comprehensive skills assessments, and qualifications should be conducted. A CRO must then match the candidate’s level of experience to the customers’ requirements.
Clinical Staffing Solutions
When it comes to clinical staffing, Orzeck notes that “AI Research’s approach is to be consultative with customers and candidates alike and they have an established approach to meeting customers’ needs. From a single resource to completely managing teams, we offer short-term or long-term contracts for a contingent workforce with experience that crosses all phases, therapeutic areas, skill sets and geographies.”
They also work closely with hiring managers to ensure direct-hire or permanent placement of candidates to match required experience and culture. The best CRO’s are positioned to rapidly staff programs with experienced resources across a wide variety of therapeutic categories such as oncology, cardiovascular, pain, neuroscience, and infectious diseases/vaccines.
As the Director of Business Development at AI Research, Greg Orzeck states that a robust and impressive business plan is key. Banks and investors will balk at backing a CRO that relies on favorable guestimates instead of hard evidence. Some Clinical Research Organizations might also be able to get clients to cover some of the costs, which can be a win for all involved.