Vice President, Vault RIM and Safety, Veeva Systems

John Lawrie

As life sciences and medtech companies settled into new operating models and remote ways of working over the last year, many came to realize that a return to pre-pandemic days was no longer necessary. The accomplishments and innovations of last year will pave the way for long-term changes across research and development operations in 2022.

Powered by learnings and insights from having more robust data, companies will achieve new levels of efficiency that will result in more patient-centered care. Here’s how Veeva envisions this coming together in the year ahead.

A single, centralized platform for data will be fundamental in shifting to hybrid digital trials

As clinical leaders advance from decentralized approaches to more connected digital trials, many are realizing the importance of having a strong data foundation. Patient data must be aggregated and cleaned, if it is coming from new sources such as wearables, to connect it with trial and clinical operations data. Most organizations are employing “brute force” manual methods or hiring a small army to map and clean data from digital sources.

Enabling better clinical trials requires the ability to be adaptive in design and execution so allowing more effective data management, with technologies that automate and speed processes, will be a top priority and a fundamental first step for companies moving toward true digital trials. Using data management tools that ingest, aggregate, and clean data will make it easier for clinical teams to analyze and share reliable information during study conduct.

With clean and accessible clinical data on a single platform, users benefit from real-time visibility and greater insights. As companies deploy hybrid digital trials, this data foundation will enable a seamless flow of information across functions and stakeholders to drive better collaboration, decision making, and speed.

Artificial intelligence increasingly drives efficiency, process improvements in trials

The adoption of purpose-built eTMF applications 

. The move from paper to digital has fueled positive change in the industry, enabling organizations to manage their trial master files (TMF) more actively and optimize their processes. Looking ahead, artificial intelligence (AI) in TMF will increasingly drive efficiencies and enable strategic process improvements for long-term success.

One leading clinical-stage biotechnology company adopted AI within their eTMF to help process documents quicker. They identified that site management documents were frequently duplicated during the handoff between the site start-up team and the monitor’s first on-site visit after site activation. With AI to auto-classify documents, they could process documents and increase visibility for those documents across teams more quickly—reducing the risk of duplicating them.

AI offers tangible ways to improve day-to-day operations and replace transactional activities, like document classification, with strategic activities that support long-term success. In 2022, we’ll see more stories around the successful application of AI in clinical trials, enabling greater flexibility and speed in execution.

Pharmacovigilance transformation hits high gear

R&D may have been one of the last areas in life sciences to modernize and transform its operations, but the use of new business approaches and technology have had a significant impact on operations within clinical and regulatory. Pharmacovigilance is now hitting its stride as more companies reimagine how they handle case intake and processing, in parallel with their document management needs. Safety departments are also taking a more proactive approach earlier in drug development and investigating more advanced technologies for signal detection, analysis, and management.

This year, automation and finding new ways to process data will be vital to improving patient safety and maintaining compliance. So will simplifying data management systems, their validation, and ongoing maintenance. We’ve seen more than 50 life sciences companies, from small innovators to large enterprises, 

modernize pharmacovigilance data management

As the technology modernization trend continues next year, safety departments will focus on the opportunity to manage their end-to-end pharmacovigilance processes and information more holistically, in a more efficient and compliant manner.

Diagnostics and pharma forge a better path for personalized treatment

The genomics revolution is accelerating as costs drop and disease states expand, driving increased collaboration between genomics organizations and pharmaceutical companies. With no sign of slowing, these partnerships will redefine precision medicine with new companion products (CDx) personalized for the patient and therapeutic drugs. As a result, companies will be able to better identify risk of adverse events or opportunities to adjust treatments for higher efficacy.

With a collaborative, patient-centric approach, the collection and sharing of outcomes will be critical for future advancements. This will lead to a shift toward more connected, digital landscapes that enable seamless and automated data exchange across stakeholders.

European regulatory requirements get real, driving massive change in operations

The industry has been preparing for EU MDR and IVDR for nearly five years, yet more critical work remains to ensure compliance. This is especially important as companies adapt to changing market conditions and growing global demand.

An area in need of transformation, for example, is claims management. Claims are continuing to get narrower and more defined. To adequately manage claims under regulatory changes, companies need to connect regulatory and marketing content operations processes. Regulatory teams leveraging end-to-end claims management processes can drive faster reviews and approvals, improve compliance, and gain insights into actionable data like claim usage and campaign performance.

As the clock ticks towards the full implementation of EU MDR and IVDR, the industry will continue to modernize operations to establish a stronger data foundation, improve connections across cross-functional teams, and drive real-time visibility into data and content. If companies can do this, they will be much better prepared for implementations.

With more industry changes on the horizon, a growing number of life sciences companies are reimagining their operations. The 

shift to digital and connected systems is well underway

, driving greater efficiency and speed across product development. Positive change is happening across R&D, supported by modern technologies. This will help companies keep pace with evolving market dynamics—from regulatory updates taking effect like IDMP to changing patient expectations—and accelerate the development and delivery of life-saving products to the patients that need them.

, Vice President, Vault R&D and Quality, 

, Vice President, Vault RIM and Safety, and 

, Vice President, Vault MedTech; all with Veeva Systems

Articles

Pandemic sparks new long-term plan for success in R&D.

John Lawrie

Articles

How Digital Will Transform Product Development in 2022 and Beyond