CROs, sponsors, service providers, ethics committees, regulators and government bodies – including Quintiles, Parexel, Pfizer and AstraZeneca – have shared services free-of-charge with clinical research sites via the non-profit Alliance for Clinical Research Excellence and Safety (ACRES).
The initiative places networking technology at investigator sites, allowing them to share their trial information instantly with sponsors, institutional review boards (IRBs) and regulators.
The network can answer queries in real-time from these organisations about whether clinical sites have correct accreditation, for instance doctors’ qualifications, speeding up trial set-up.
Changes to the Declaration of Helsinki last October tightened documentation requirements for physicians conducting studies in humans:
“Many times [certification] of medical licenses and diplomas are not up-to-date and sponsors spend thousands of dollars trying to collect this information to get a site on board a clinical trial,” ACRES board member Al O. Pacino told Outsourcing-Pharma.com.
But there is no centralised repository for uploading these documents.
“When Bristol Myers-Squibb runs a clinical trial, they collect that information from every investigative site. The same goes for AstraZeneca, etc. So when a site runs 10 or 15 trials, they have to upload this same information 10 to 15 times.” IRBs and national regulators will also require the same information.
The process creates redundant information “silos,” said Pacino, wasting time and other resources for all drug development stakeholders.
$102m and counting…
Using ACRES as a non-profit conduit, pharma companies have pledged free systems for research units to deposit this data just once. Clinical trial investigators are already required to maintain this information locally in case of a regulatory audit – the ACRES initiative allows other stakeholders to access it and could create a global process and set of standards, said Pacino.
The agreement works by alliance members pledging tens of thousands of software licences to ACRES, which distributes the tech to research units. The system is cloud-based, with ACRES providing “just the glue” and not maintaining databases, said Pacino.
HealthCarePoints – of which Pacino is the CEO – has given software to the project which checks trial investigators’ credentials. Verified Clinical Trials has pledged its software for preventing dual patient enrolment, Pacino said, opening up the technology to Phase I units without the means to purchase it. Japanese tech giant Fujitsu has been “providing the IT backbone since they came on board about four months ago” with an electronic medical records system, said Pacino.
ACRES’ stakeholder consultations are attended by 100 of the biggest pharmaceutical players, Pacino said, with the most recent June meeting opened by Pfizer Chief Medical Officer Freda Hall.