Big Pharma goes on to drive the demand for contract resource organizations- CROs by way of outsourcing almost 45% of research and development activities. It is well to be noted that the global biotechnology as well as pharmaceutical services outsourcing market is all set to grow to $108 billion by 2030 so as to meet these demands that are rising all the way, putting immense pressure on CROs.
Many CROs go on to believe that they have gone on to reach a breaking point as they go on to work to keep up with increasing case volumes, data intricacies, and regulations that keep changing. To combat such pressures, CROs require access to modern pharmacovigilance- PV automation that goes on to promote flexibility, efficiency, scalability, as well as cost-effectiveness.
TRADITIONAL SAFETY PROCESSES – NOT ENOUGH
Numerous CROs go on to rely on tedious and outdated manual methodologies so as to handle the safety data influx as well as process cases. Those traditional workflows go on to make it more challenging for the CROs to accomplish these essential tasks:
Efficiently Process the Data- Â The first steps within the safety case processing involves extracting safety case elements from the source documents and also populating that data into the database. Traditional, manual approaches go on to typically require the PV teams to carefully assess the incoming documents as well as forms before rekeying the information into a case-in-take system. This process goes on to involve expending manual efforts in terms of redundant data entry and hence requires numerous stages of manual reviews as well as quality checks, thereby resulting in an error-prone as well as monotonous data entry flow.
Scale the Cost-Effectively- Traditional workflows go on to impair a CRO’s capacity to process hierarchies, make adjustments to changes in volume, and also, at the same time, introduce new services. In turn, the drawback makes it steeper to scale operations and also become a one-stop-shop vendor. While making use of the legacy systems, CROs have to put in place more human resources, and that too at increased case volumes, which is not sustainable in the long-term.
Determine Safety Signals- Discovering safety signals happens to be a critical aspect of pharmacovigilance. A manual review of the individual cases or data may even make it quite challenging for PV teams to efficiently gauge the patterns, trends, or even potential safety issues. Organizations may also go on to miss essential signals or even face delays when it comes to detecting and acting upon safety issues that happen to be emerging.
Meet Intricate Global Operations- PV operations happen to be subject to stringent regulatory requirements and reporting obligations. Traditional workflows may go on to lack built-in compliance checks and also automated reporting mechanisms, making it even harder for CROs to make sure of compliance with evolving standards as well as regulations. Dependence on manual processes can go on to introduce errors, inconsistencies in the data, and delays when it comes to meeting regulatory deadlines.
By way of embracing modern tools as well as technologies, CROs can overcome such limitations and go ahead and optimize their PV activities, thereby leading to better delivery when it comes to offering more value to their clients.
AN INDUSTRY REQUIREMENT FOR AUTOMATION
Recent trends throughout the life sciences sector also go on to create a requirement for faster and more precision-led adverse events- AEs reporting. Safety caseloads happen to be increasing by 15% YoY, on average. This surge can very well be attributed to a number of factors, which include:
The Changing Regulations – The US Food and Drug Administration- FDA as well as the European Medicines Agency- EMA continually go on to update their safety data reporting needs. Increased regulatory scrutiny so as to ensure patient safety will keep driving the requirement for more PV capacities and for organizations to review as well as revise their safety cases.
Elevating Clinical Trial Complexities – More clinical trials go on to require larger patient populations because of the increasing prevalence of chronic diseases as well as the need for additional data so as to support the approval of novel treatments and drugs. Larger patient populations happen to make clinical trials more intricate as PV teams go on to manage as well as track a large set of patients. Clinical trials are also becoming very globalized, with the CROs going ahead and conducting trials throughout the study sites across multiple countries. This reach needs coordination when it comes to different teams and also compliance with distinct regulations. Additionally, CROs happen to be conducting clinical trials across numerous diverse therapeutic points that need a broader range of expertise.
Elevate Adverse Event Data – It is worth noting that more cases or patients experiencing AE of interest happen to be emerging during post-approval drug safety surveillance. Throughout the monitoring of the safety as well as effectiveness of drugs presently available in the public domain, PV teams go on to identify a requirement for preventive actions such as changes in product labeling information as well as, but rarely, re-evaluation when it comes to an approval decision.
Advanced technology within the life sciences sector also goes on to contribute to the increased AE data. More organizations make use of electronic data capture- EDC systems, thereby enabling the efficient collection of more information. Patients are also making use of social media platforms so as to report AEs. Social media goes on to empower the patients to take an active role in their health by way of providing an outlet so as to share their experiences with regards to the treatments. This unsolicited RWD systematically goes ahead and also adds valuable context to the signals found in the reported AE data sets. But because technology goes on to make reporting easier, there also happens to be a rise in the number of false or even incomplete reports that require to be logged and also processed.
Given challenges such as these, the CROs require intelligent and innovative technology in order to help with growing case volumes.
DIFFERENT KINDS OF AUTOMATION
When in case of considering which technology capacities best sync with their PV endeavors, CROs must look at these three kinds of automation:
Rule-Based Automation – This goes on to apply man-made rules to the store, sort, as well as manipulate data. Rule-based automation best takes care of repetitive tasks such as duplicate checks.
Knowledge-Based Automation, which is Artificial Intelligence- AI, Natural Language Generation, or Machine Learning- ML goes on to unlock insights into large data sets that are related to compliance as well as patient safety. This goes on to have sophisticated algorithms that do tasks that require cognitive reasoning, speech recognition, visual perception, as well as decision-making.
Knowledge-Assisted Automation, which is Natural Language Processing- NLP or Machine Translation, goes on to combine the power of automation along with human insights as well as expertise so as to achieve more efficient as well as effective outcomes. Knowledge-assisted automation goes ahead in addressing increased case volumes and can handle structured or unstructured case sources much better. Examples of knowledge-assisted tasks go on to include causality evaluations or even literature database screenings.
Automation helps in pushing efficiency and also offers benefits such as greater process consistency, enhanced data quality, as well as the opportunity to alter and shift resources to higher-value initiatives such as PV analytics and benefit-risk evaluation. But the fact is that technology should not replace all the work that humans do. Rather, it should act as a push to help humans get their jobs done better and also transform safety from a cost center into a more strategic pillar of innovation.
HOW AUTOMATION GOES ON TO BENEFIT THE CROs
It is well to be noted that before taking the steps to execute automation, CROs should go ahead and consider the advantages that are specific to their operations, which could include the following:
-Decreasing manual efforts as well as repetitive tasks.
-Aiding the CROs comply with regulations that are changing while at the same time also reducing the risk of inconsistencies as well as errors.
-Making sure that distribution protocols adhere to each region’s regulatory requirements.
-Streamlining PV operations and reducing expenses, as well as the time that happens to be associated with the linear data processing.
-Thwarting the data silos that keep CROs away from gleaning insights.
-Enabling the data streams from other sources as well as systems to connect, leading to better risk evaluation as well as decision-making.
In practice, CROs make use of automation so as to extract information from the inbound data forms, explore relevant safety data points, and also annotate such data points from literature articles. Leveraging automation so as to take care of those manual tasks goes on to free PV teams to redirect their attention towards more valuable activities, such as understanding what those data points go on to mean. Resources having high levels of specialization can go on to be alerted when cases fall outside of the predetermined thresholds, which again require humans to come up with decisions using their judgment.
CHALLENGES PERTAINING TO ADOPTING AUTOMATION
Significantly, automation can indeed be a valuable tool for CROs; however, automating PV workflows is not always that simple. CROs may as well have to navigate the following barriers:
Training – PV teams have to go through training so as to strengthen their knowledge when it comes to automated systems. This education can indeed be a challenge if employees happen to be under time constraints because of heavy caseloads or resist change- we have always done it that kind of mentality.
Integration – CROs must go ahead and integrate the automated systems with the existing PV systems, as well as processes that go on to often have in them multiple teams, which can be complex and even time-consuming.
Maintaining Data Quality – CROs require clean, accurate, as well as complete data so as to ensure automated processes go ahead and also produce reliable results. The best safety solutions happen to include intelligent automation pretrained having an incredibly extensive data set.
Making sure of Compliance – CROs must go on to ensure that their automated systems happen to be comply with regulatory needs, such as those that are related to safety reporting as well as data privacy.
In spite of these challenges, CROs can go ahead and successfully adopt automation with careful planning as well as the right automated safety solution.
SAFETY PRIORITIES IN CASE OF CROs
When in case of replacing traditional workflows with the modern safety solution, CROs must go ahead and seek a versatile cloud-based solution that helps a single source of truth for enhanced data quality. An automated end-to-end solution must go on to include the following qualities like-
Flexibility- Adapt to an organization’s distinct requirements with flexible configurations of workflows, dashboards, and even the reports.
Speed – Increase the rate at which specialized treatments happen to arrive on the market. With automation, CROs can go on to see a 30% dip in time so as to complete clinical site tracking reports.
Scalability – Strengthen full-service model through seamlessly scalable post-market safety operations.
Efficiency – Delivers more with similar resources having an end-to-end production-ready automation. CROs can go on to achieve almost 30% efficiency gains by way of using automation solutions.
Always Up-to-Date International Compliance – Expand a CRO’s serviceable market by way of support for all current as well as upcoming regulatory norms.
Moreover, the fact that clinical trials happen to be increasingly global can go on to add to data issues. An absolute cloud-based clinical trial management system can make it easy for CROs in order to manage data centrally and hence thereby, achieve cost savings.
TIPS WHEN IT COMES TO ADOPTING AUTOMATION
After opting for the right safety solution for their requirements, CROs can go ahead and abide by these tips so as to adopt automation:
Assess the present Processes – CROs must assess the actual needs as well as pain points within their PV operations. By way of understanding the present processes, CROs can begin pinpointing the areas in which automation can go on to bring the most prominent benefits, like data entry, case processing, or even reporting.
Start Small – CROs, apparently, should not try to automate everything all at once. Rather, the PV teams can go ahead and start with certain key processes and then scale up as they get experience. A slow pace helps to keep the employees from having a feeling of being overwhelmed and helps with successful automation adoption.
Provide Training as well as Support – CROs must go ahead and provide absolute training to employees who are going to work with automation tools. Education is critical to making sure that staff members comprehend automation’s benefits, know how it operates, and can go ahead and effectively leverage its capacities. Ongoing engagement as well as communication all across the implementation process will go on to address concerns as well as promote buy-in from all the stakeholders.
Track as well as Evaluate – PV teams have to consistently track and evaluate the performance of their automation solutions. Key metrics such as processing times, error rates, adherence to compliance, and resource utilization will aid in identifying areas when it comes to optimization and improvement. Consistently assessing automation’s effect when it comes to achieving defined objectives will help with necessary adjustments.
Embrace continuous Improvement – CROs should make sure to continuously look for opportunities for enhancement by way of leveraging feedback from users as well as stakeholders. Frequent evaluation of automation’s effect on operations will go on to identify areas in terms of refinement or expansion. Going ahead with a culture of consistent improvement will go on to maximize the advantages of automation within CROs’ operations.
CONCLUSION
Many CROs go on to realize the powerful impact that PV automation can have when it comes to their operations. As a matter of fact, almost 75% of life sciences organizations remark that the opportunity to have automated risk management as well as safety signal detection can be beneficial, or, for that matter, even game-changing.
Having automation, organizations can go ahead and designate fewer resources so as to process and sift through the majority of cases as well as data. CROs go on to have better outcomes since PV teams can get to work faster as well as smarter having reliable data just at their fingertips.
