CRO

Life science sector gearing up digitization strategies to cover clinical trials

Digital technology has more to offer life science companies than making their manufacturing more efficient, it can have benefits far earlier in a drug’s development.

Clinical trials are crying out for their own digital transformation, if the results of a new survey by industry association the Ethical Medicines Industry Group (EMIG) and data archive provider Arkivum are anything to go by. They examined how digital technologies are changing the industry by quizzing 305 executives, including representatives of 171 drug companies and 15 clinical research organizations (CROs).

The major finding is that drugmakers need to think beyond production processes when it comes to digitization, according to EMIG chairman Leslie Galloway.

“The majority of digital transformation strategies now focus on improving productivity through streamlining processes while reducing costs,” Galloway said in a statement. “But a digital transformation strategy can and should transcend business concerns: it has the potential to drive human progress and change global health.”

The use of historical data in clinical research is one area where digital tech could make a difference, said Galloway, who cited the international collaborative Together trial of potential COVID-19 therapies as an example.

“This was the first trial to demonstrate that a low-cost repurposed medicine (fluvoxamine) could prevent hospitalizations for COVID-19. It evaluated nine different interventions and managed to eliminate six of them as ineffective at a very early stage, thereby saving both time and money,” Galloway added.

“This only proved possible because researchers were able to access existing clinical data. A data strategy should be at the heart of any digital transformation strategy if we are to continue to drive economic growth in this important industry sector.”

According to the survey, most companies in the trials sector agree. Some 73% of respondents said they are likely to invest substantially in technology to facilitate interrogation of clinical data on a large scale in the near future.

Data integrity is another area where digital technologies could aid clinical research, according to Arkivum CEO Chris Sigley, who told FierceCRO that contractors and sponsors sometimes struggle to maintain data.

“Current strategies often assume a level of security with records, clinical data stored on physical devices or in cloud storage,” Sigley said. “But without any archiving or preservation techniques in place, sponsors and CROs risk corruption and the records and data can become obsolete. This increases the risk of a negative finding during an inspection and makes it impossible to interrogate data on a large scale.”

To avoid such issues, having the right information management strategy is vital, the CEO argues.

“It’s about having a complete strategy so that clinical data and files can be interrogated quickly and on a large scale,” he said. “Sponsors and CROs need to ensure they are taking a complete and informed view when adopting new technology, and don’t just chase technology which offers the most obvious and recordable gains.”

To do this, clinical trial providers should implement a connected strategy and make sure that they are working with providers and technology that promote interoperability, Sigley added.