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Business success in clinical research is elusive.
Like all business, including clinical research, to be successful or to be able to provide the service you hoped for, it is important to ensure viability and sustainability of your enterprise first. By this, I mean quite simple things, such as being able to assure your team that their position is secure, to reinvest in them, to attract new staff to your business, being able to take calculated developmental risks, diversifying your services, adding infrastructure, and ultimately just lasting in the environment.
Leveraging marketing insights such as developing buyer personas for your research site can help you to better understand your customers, clients and even participants. This can make things considerably easier when tailoring your site’s content, messaging, service development and trial conduct to the specific needs, normal or expected behaviours, and concerns of different clinical research stakeholders.
You may know your target buyers are pharmaceutical companies or CRO’s, for example, but do you really know what their specific needs and interests are? What is the typical profile of your ideal buyer? To establish an appropriate insight into what drives your customers, it’s critical to develop detailed personas for your business.
The most effective buyer personas are based on a combination of your experience, market research, as well analytic or metric data that you gather from your actual client base (satisfaction surveys, etc).
In my personal experience, clinical care had always been the easy part of getting into research; I’d been looking after patients for 17 years. It was always the business of clinical research that was the steepest hill to climb. I guess, after numerous years, I have gained a bit of perspective and realise the importance of knowing who you are working with and what their priorities are, so you can start to prospectively anticipate specific demands and supply them appropriately.
Over the last few years, I have heard, more than once, stakeholders from within the clinical research industry say things like, “research should be cost neutral for sites”, or that within a multisite study “all sites should be paid the same”. In response to this, I have honestly always thought, really? Why? As a site manager, I struggled to understand how you could have effective, efficient, compliant research, without a trained and valued team in an appropriately equipped facility, if you worked toward what was essentially a financial disincentive. To add to that, if you have worked diligently and earnestly over years to establish, justify and prepare evidence-base standard sites fees, then why was there an industrial expectation to regress to the mean? If one site hadn’t developed, prepared or justified their costs, should another be penalised for that? Was there any incentive to be unique?
What I realised is that the standard engagement or negotiation system is, at times, a bit skewed, probably not always reflective of all the current costs associated with conducting clinical research, and highlighted a certain lack of insight into the key stakeholder in clinical research – the sites. It’s not personal, it’s business. So, quickly as a developing site, apathy needs to be done away with in the view to forge your own model for success, create you own KPI’s that define prosperity, and despite your level of experience, don’t be discouraged when people say, “that won’t work”, because in my experience, with due diligence, it has worked, every single time.
To create more opportunity and more value for you research business, you really need to consider exactly who your customers are. To convince people you are, in fact, worth it, means backing up everything you say. Remember, fundamentally it is in the customer’s advantage to try to turn your trial conduct service into a commodity, because then the issue becomes narrowly focused on an itemised price. Until you have the opportunity to set yourself apart from your competition, you cannot establish why you are worth your price. You need to stay in touch with what is happening in the marketplace and especially what other sites who offer the same kinds of services you offer.
To do this, you need to ask yourself a series of questions:
For a research site, your consumers may include Pharmaceutical, Biotechnology, CRO’s (large scale/boutique) and trial participants. You may be engaging with and marketing to Clinical Research Managers, Project Managers, Directors or Clinical Research Associates, just to name a few. Beginning to empathize with these clients is a good place to start.
Once you consider and characterise your own customer base or users, you can gain a greater understanding of what they are trying to achieve. It helps you develop your business profiles and strategies and look at things in a commercial sense, as opposed to standard medical or hospital settings, for instance. If we use a Sponsor as an example, the things that they are trying to achieve may be (amongst other things):
Furthermore, if we consider what is most important to a sponsor when using your site’s service, there are some obvious expectations and assumptions, as well as some less recognisably valuable potential inclusions. Each item you identify as important to your customers drives the direction for where you should focus any business development in response. I have included a few examples below:
What is your recruitment system? Do you have one? What pathways do you use? How quickly can it be deployed? How many ways can you ethically access potential candidates for your study? What systems should you use for trial communications and what are the most cost effective? Once your recruitment system is created, how will you advertise it or highlight its appeal to win more business?
Establishment of a contemporary recruitment and multi-platform communications strategy is an essential opportunity to create value for your business and provide superior access to trials for your local population.
Do you have the appropriate investigators for the study? Are they insured, GCP trained and registered? If you want different or more diverse studies, how will you attract new investigators to your team? What reimbursement model will you use? Do you have standard agreements etc?
When your investigative team is set, advertise their profile on the numerous clinical trial site portals online and on your website, and notify any CRO site selection or feasibility representatives to promote their speciality and thereby your site’s access to relevant study populations to win more business.
Good coordinators are like gold. A well-qualified, proficient and personable CTC can provide an immense boost to your customer service profile and reputation. A bad one can do just the opposite.
For any clinical study, the sponsor, CRO, or both are going to want to see your standard fees. This is an obvious expectation and considerable amount of work needs to be done to create a fair and reasonable baseline of costs that can be adjusted based on many factors unique to each individual protocol.
Annual or even post study review is recommended to ensure proactive financial responsibility. If you just react to each budget negotiation you’ll never gather real internal evidence that truly justifies your worth.
In a perfect world, it would be ideal to have a nice room for sponsors to not only meet your investigators and research team, but to be able to sit and have space to monitor study data when the time comes.
This may not always be possible, but small things like a bowl of fruit, fresh water, or even burning a scented candle, for instance, shows your customer delegates that you care and can help to foster a positive relationship.
To be able to conduct a certain number of clinical trials, a site requires a reasonable amount of basic equipment. This may include fridges, freezers, incubators, ECG machines and a significant amount of secure storage space.
Measured investment in appropriate equipment to actually conduct particular trials is investing in both scope and potential in your research site.
Ultimately for your site, the specific problem you can help a sponsor with is conducting a study, per protocol, in your geography, according to the CTA that is:
If you can maximise your site’s ability to provide these assurances, add some innovation, and always apply sound quality management principles, you can quickly evolve your business and mature your knowledge of the market you have chosen to compete in.
After that, you can start to work on you own Unique Selling Proposition…
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© Genesis Research Services, 2023