A Philadelphia company has created a new industry business model by providing concierge services to patients participating in clinical trials.
Clincierge, a division of Gray International Consulting, tackles the logistics of clinical drug studies, allowing pharmaceutical manufacturers, clinical study site leaders and their staffs to focus on patient care instead of booking hotels and airline flights and obtaining medical travel visas.
From a single drug trial three years ago, Clincierge now works on 34 active clinical trials for 12 different pharma and biotech firms, including Alnylam Pharmaceuticals, AstraZeneca, Ultragenyx Pharmaceutical and Vanda Pharmaceuticals. Clincierge staffs sites in 30 countries and offers services in 23 languages.
With the Rise of AI, What IP Disputes in Healthcare Are Likely to Emerge?
Munck Wilson Mandala Partner Greg Howison shared his perspective on some of the legal ramifications around AI, IP, connected devices and the data they generate, in response to emailed questions.
The company evolved to address a vexing industry problem. To obtain federal Food and Drug Administration approval, drugs must be rigorously tested on statistically significant populations of patients who have the specific disease or condition the drug is aiming to treat. Drug companies typically contract with physicians treating those diseases to do so.
For rare diseases, patients often must travel great distances to reach study sites. Medical site staffs often must book flights and hotels and arrange visas and other travel arrangements for sometimes very sick patients. Patients incur great expenses many cannot afford.
That partially explains the 30-35 percent dropout rate of clinical trial subjects before study completion. Dropouts require study sponsors to add new patients or extend the trial period, potentially costing millions of dollars more in study expenses and risking the loss of “first to market” advantage. Even recruiting patients in the first place is challenging, as many patients are reluctant to commit for the two-to-five-year trial periods.
Clincierge capitalizes on Gray International Consulting’s quarter-century experience in convening international meetings for the pharmaceutical industry. In addition to booking flights, hotel and other travel arrangements and overseeing logistics, Clincierge offers study participants debit cards for travel purchases and reimbursements and offers fast reimbursement.
A Personalized Approach to Medication Nonadherence
At the Abarca Forward conference earlier this year, George Van Antwerp, managing director at Deloitte, discussed how social determinants of health and a personalized member experience can improve medication adherence and health outcomes.
The company said patient out-of-pocket expenses drop and that study participants can communicate with local Clincierge staff in their own languages.
Mary West, associate director of clinical operations for Cambridge, Mass.-based Alnylam, said her company currently oversees 25 clinical trials, a figure she said could double in a few years.
“We’ve gone to Clincierge for help in obtaining medical visas and other travel documents. One of the big things they do is make it easy for patients to get to the sites without having the burden of dealing with all the logistics and relieve the medical staffs from having to coordinate all that. They’re happier to focus on patient care, which is what they do best.”
Scott Gray, co-founder and CEO of Clincierge and CEO of parent company Gray International, said communication, logistical challenges and high out-of-pocket costs pose barriers to clinical study patients.
Gray said there is uniqueness to rare-disease trials.
“The patient populations are not as concentrated as with a common disease like diabetes,” Gray said. “Setting up treatment close to home is often not logistically possible. There may be only one treatment site in all of Europe, and we may have to fly patients to that site from as far away as India.”
Photo: Flickr user Memphis CVB
