Pharma Focus Asia
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Bruce Palsulich, Vice President, Product Strategy, Oracle

The use of traditional paper-based case record forms (CRFs) are becoming a thing of the past as Contract research organisations (CROs) increasingly embrace digital transformation, enabling more accuracy and reliability of data, security in pharmacovigilance, collaboration, innovation, and speed of operations.

Pharmacovigilance (PV) is increasingly taking its toll on life science organisations. According to EY research1, large pharmaceutical companies contend with an average of 700,000 adverse event (AE) cases each year, a number that IDC2 has found to be rapidly increasing by 30 to 50 per cent annually. The pandemic has exacerbated the situation, with the fast tracking of COVID-19 vaccines increasing AE caseloads to more than one million a year for some industry players.

A Digitalised Future for Pharmacovigilance

Companies are under pressure to manage this increased case load effectively while still maintaining their current cost base. Data sources are proliferating, challenging safety teams to make sense out of the jumble of data points to produce valuable insights, while also satisfying divergent regulatory requirements for safety reporting – all of which contribute to increased cost for PV departments.

This means that safety teams need to be more efficient in managing their workloads. The question is, how?

Reshaping PV Processes for the Digital Age

What if pharmaceutical organisations could accurately forecast adverse events or quality compliance issues before they took place, or receive real-time feedback throughout the drug lifecycle directly from patients to eliminate lead times and delays?

To bring this into reality, pharmaceutical PV organisations need to move into a “digitalised future” where technology plays a key role in PV processes. This includes automating and streamlining the information streams to reduce complexity, from case processing to reporting. Once automated, companies need to begin to look to artificial intelligence to add further value from their data.

By applying artificial intelligence (AI) and data science approaches, organisations can turn the overabundance of data from being a challenge to solve, into an opportunity. A well-designed, automated, AI-powered PV system can not only eliminate tedious and repetitive tasks but also reduce human errors and analyse massive volumes of data efficiently. This can even empower teams with predictive signal detection capabilities with insights derived from integrating disparate big data sources. Ultimately, this can enable specialists to make more informed observations and recommendations on product safety.

The Building Blocks of Digital PV

Pharmaceutical organisations, however, need to be cognisant that technology is not a solution unto itself. Success in digital PV should start with a foundation of both digital and operations transformation. To derive the most value from a digital approach to PV, teams will need to build complementary capabilities such as:

• Having the right people in the right roles: New skills are essential to the next-generation PV team. In the typical PV department today, there’s a gap between the medical skills and technology skills of any given staffer. Companies will need to invest in building the PV workforce of the future by upskilling and building cross-functional teams at both management and operational levels. While finding people who have both skillsets may not be easy in a time of a global talent shortage, this will be essential to making the most of the technology that’s on the horizon.

• Empowering patients: Patientcentricity has become a hallmark of not only high-quality health care, but also high-quality PV processes. A true patient-centric organisation means connecting with the patient throughout the entire lifecycle of the product,  from trials to market. Patient involvement early in the trial design process can provide teams with invaluable feedback to identify required improvements, allowing for the development of new digital products that best meet patients’ needs under real-world use conditions.

• Collaboration – internally and externally: Breaking out of silos is sound advice for any function in any business today, but it’s doubly important to PV teams who have responsibility for something as important as patient safety. So, it’s important that safety works across functions inside the company in order to keep the patient at the centre. It’s also important to build external collaborations – within the industry to share best practices and build data resources; with regulators to help guide rules so they ultimately benefit the patient; and with technology companies and those in academia to help drive and shape change.

• Embracing a culture of innovation: To be able to integrate and use technology to its best potential means it is critical to foster the right culture to embrace innovation and be datacentric in your thinking. That is what will enable predictive safety, provide useful insights across the company, and increase efficiency. A next-generation, digitalised PV department is pioneering and able to drive change across the business.

Putting the above into practice will be essential to create the foundation for a next-generation PV department as the industry continues to move to a digitalised future.

DiagnoSearch – A Real World Example of Success

India-based DiagnoSearch, a full service contract research organisation (CRO) is increasingly benefiting from embracing digital transformation. The company’s services cover every aspect of clinical study – from phases 1 to 4 – including PV, clinical operations, data management, bio-statistics, central laboratory, and protocol and clinical study writing for pharmaceutical, biotech, and vaccine manufacturers.

“We used to rely on paper-based case record forms (CRFs) to record data and other information on each trial subject,” said Mandar Vaidya, vice president at DiagnoSearch. “Though its format is designed to allow for accurate input, presentation, verification, audit and inspection of the recorded data, using CRFs has become more challenging as our business grew.”

India-based DiagnoSearch has been in the business for 27 years, and has since extended its geographical footprint in Australia, South Africa, Kenya, Uganda, Zambia, Gambia, and Mali. “As our business continues to grow, so is the data that we have to handle and analyse. Delayed data entries, printing issues, human errors, and the like, which were associated with our old paper-based CRF system had to stop,” added Vaidya. “We value our reputation and we offer high quality services based on the best science and technology of the day.”

DiagnoSearch now uses an integrated platform for all its clinical trials, including robust and time-tested database solutions that provide accuracy, reliability, and efficiency – from data collection to data integration, to analysis, to reporting. Using cloud services also enables seamless budgeting that brings transparency to the business. All this has helped the company reduce project timelines and improve data quality, which increased overall productivity and business outcomes. Likewise, DiagnoSearch’s customers continue to benefit from improved efficiencies, including shortened timeframe for starting up, conducting, and closing out every clinical trial study – and above all, accurate clinical trial results that help ensure drug safety.

The Future of PV

The shift to a digital-first economy continues to drive the need for digital transformation – essential to avoid being disrupted, and to remain competitive. Pharmaceutical organisations that have yet to take the step toward digital transformation should now plan for and lay the groundwork for digital PV processes. The key is to adopt a stepwise approach, including digitalisation and cloud adoption that will lay a robust foundation to support further technology adoption and business growth.

As capabilities evolve, a phased approach to introducing technologies such as AI into the pharmacovigilance process can pay significant dividends. As organisations and safety teams become more comfortable with automation, they will gain the knowledge and confidence to increase and adjust autonomous workflows accordingly for optimal outcomes.

While challenges such as those pertaining to regulation will no doubt remain, organisations that begin the transformation processes now will benefit from technologies sooner, improving their safety management in a highly competitive business environment.



--Issue 47--

Author Bio

Bruce Palsulich

Bruce Palsulich is responsible for the strategic direction of the Oracle Health Sciences Safety Cloud – an integrated suite of the market-leading safety case management solution (Oracle Argus), and the market-leading safety signal management solution (Oracle Health Sciences Empirica), delivering unified end-to-end multivigilance throughout the entire lifecycle of medicinal products.

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