Have You Dated People Like Me Before?
Three years ago, smaller CROs had their pick of small to mid-size clinical research studies sponsored by similarly-sized biopharmaceutical and device companies.
These studies usually didn’t attract much interest from larger CROs because they didn’t offer the same revenue potential as larger studies. Smaller sponsors with fewer internal resources needed a higher level of customer support, so they appreciated the customer focus offered by smaller CROs.
The situation is changing fast, with economic factors driving large CROs to pursue smaller sponsors’ clinical studies. But the growing interest of large CROs should give small sponsors some hesitation. If I wasn’t attractive to you before, why am I now?
Do We Have Similar Lifestyles?
Do you need a niche or full-service CRO?
A large international trial with over 200 sites and several countries needs a large global CRO with unlimited resources. But a smaller pain or urology study with 100 sites in the U.S. and Canada will benefit from a smaller CRO that focuses on smaller customers. And, if the sponsor is U.S. based and the CRO isn’t, the sponsor will have to deal with a different corporate culture, work ethic, and contract.
If you only need pieces – study management, startup, or monitoring – the smaller CRO is a faster, less expensive option. If you want to be sure the services you buy aren’t subcontracted, you want a smaller CRO.
A niche CRO that provides smaller sponsors with a personalized level of quality and service will have a history of knowing what its customers need from a CRO.
If your study needs to be up and running in three months and you haven’t even started the CRO selection process, avoid larger companies that can hold you up in red tape. The big CROs can’t really move faster unless you’re willing to compromise on the contract language, timeline, and the cost of the project. Smaller CROs offer more flexibility with language and cost.
How Will I Know It’s Working?
Metrics, measuring and reporting are central to conducting a successful study.
Sponsors should ask the CRO to describe and demonstrate their metrics in great detail. If they use an EDC system – which I recommend strongly for its data accuracy and efficacy – the sponsor needs to know how often the CRO monitors their sites’ data entry, as well as the query rate.
Be sure that the CRO delivers quality monitoring, and demand monthly executive reports to track the trial’s progress. The best way to decide if the CRO’s reporting meets your requirements is to review the CRO’s case studies and find out if the CRO has worked for similarly sized companies. Get at least three customer references. Ask to see the CRO’s measurements and metrics for other small sponsors, and how they met sponsors’ goals and timelines.
Enrollment and patient recruitment are just one critical factor in a clinical study. Sponsors need a written guarantee about how the CRO will give every aspect of their study high priority.
For starters, it’s vital to compensate sites for work performed and the time it takes to recruit one subject. In this competitive environment it’s easy to forget this. Although it’s wise to get the best service for the lowest cost, we have to remember that we get what we pay for. A low budget can mean low attention.
Are You Responsible with Money?
One of the most expensive, time-consuming and frustrating components of clinical study management is the change of scope. Even a small change affects the entire process. Sponsors who work with large CROs might get unrealistic budgets that balloon with every change in the process. CROs don’t want to do extra work they’re not getting paid to do, and small sponsors don’t want to go over budget and generate stacks of additional paperwork.
In my 17 years of experience in outsourced clinical study management, it’s mostly small CROs who are willing to guarantee – in writing – that there will be limited or no changes of scope, or that the CRO will eat the changes.
I Want a Pre-Nup
The time invested in compiling an RFP is directly related to the number of changes the sponsor and CRO will face. An RFP template can be a simple Word file in a table format with estimated timelines; date of first and last subject screened and enrolled; a checklist of responsibilities; and, potential challenges to help the CRO project enrolment and budget.
Partnering with a CRO of the same size and values is the best way a sponsor can ensure they get the right attention, staffing, metrics and reporting, and end results.
By sharing previous clinical study data the sponsor and CRO can get valuable budgeting information for developing the RFP, proposal, and study. What happens if the sponsor adds sites, patients, meetings, and/or monitoring visits? What if the timelines are extended? Both sides need answers before signing the contract.
Will You Support Me?
Because smaller biopharmaceutical and device companies don’t have the staff to manage an entire clinical study, they need a higher level of true collaboration and communication with their CRO. This is a huge selling point for the small CRO. Smaller CROs have the knowledge, expertise and processes to offer smaller sponsors with limited teams and budgets the knowledge, experience and processes to conduct successful clinical research studies.
A smaller CRO that specializes in working with smaller sponsors will be staffed with experienced Project Managers who understand the sponsor’s internal limitations. PMs at small CROs hold the whole trial and know every piece of it. They can guide the sponsor through every step of the process and address problems, questions and situations from startup to closeout. Because PMs at smaller CROs have experience in similar study management, many smaller sponsors look to them to help make critical decisions.
A customized communication strategy is vital for the smaller CRO and sponsor relationship. The smaller CRO should aggressively promote its track record for developing ongoing, personalized strategies that integrate every possible communication avenue – telephone, email, fax, regular mail communications – into a solid monitoring program that gives the sponsor 24/7/365 access to enrolment and compliance.
To recap, if small to mid-size sponsors use the same principles as online dating, 9 times out of 10 they’ll find that the small, niche CRO is their most compatible match.
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