Today, COVID-19 has drastically impacted global working models across industries, with no exception. Individuals in altered industries are working in varied shifts by successfully adopting a work-from-home model and delivering outputs per client obligations and regulatory compliance. Undoubtedly, the pharma and life sciences space, too, has been affected irreparably by this far-reaching crisis. During these unprecedented times, patient safety remains the utmost priority, and adverse events are tracked and monitored continuously to provide a better standard of healthcare.
On a broad scale, the existing market, quarantine periods, traveling constraints, and social distancing have all resulted in the world economy taking a major hit. Certain occupations, although characterized by high human proximity and low suitability to work from home, may well be amenable to this shift through innovation and technology-enabled business models. This new model has influenced and encouraged the use of modern tools and technology, automation, big data and analytics, and social media surveillance on global aspects.
Once this pandemic ends, it is likely that service industries and other sectors may allow 25-50% of their employees to work remotely on a more permanent basis, to be able to manage infrastructure costs and bring back some semblance of normalcy to the ecosystem. Companies’ policies and employee contracts will undergo changes to ensure that data privacy and security along with deliverables and timelines are not impacted.
The current pandemic situation has affected the management and planning of the Life Sciences and Healthcare industry along with global clinical trials. The situation has caused regulators to make changes to their strategies too. As the world continues to fight the pandemic, the Medical Device sector is continually contributing and collaborating with policymakers and other stakeholders to play its part in ensuring that people’s lives and health can be protected by uninterrupted supply. As per the WHO, “Governments should develop incentives for industry to ramp up production. This includes easing restrictions on the export and distribution of personal protective equipment and other medical supplies.”
Due to the COVID-19 crisis, the EU Commission decided to postpone the implementation of Medical Device Regulations (EU) 2017/745 (MDR) by a year – from 26 May 2020 to 26 May 2021. This allows the medical device industry and Notified Bodies (NBs) to focus on the problem at hand and put all their efforts into combating the current situation. Having the actual date of implementation might mean shortages or delays in getting the medical devices needed to fight COVID-19. Wipro as a service organization caters to (EU) 2017/745 (EU MDR) implementation globally.
Few regulators have eased norms to reach the need in this pandemic situation. On March 25, in the interest of the protection of health, MHRA announced that it might authorize the supply of non-CE-marked devices. US-FDA has opened the door of Emergency Use Authorization. Some countries have called on the automotive, aerospace, and other industries to help plug the shortages of important medical devices. Due to this pandemic, MIT created an open-source solution for ventilators. However, regulators emphasized on the safety and performance of the devices. Due to such reasons, there may be training and understanding gaps as far as healthcare professionals are concerned.
Wipro has a robust Medical Information Contact Center, which responds to >50Mn inquiries related to Medical Information and Product support enquiries. We support approximately 200 languages covering the globe, in addition to meeting the needs of local language speakers.
The FDA acknowledges that companies and the agency itself may be hit by workforce shortages during a pandemic at the same time as adverse event reporting for products deployed for the pandemic may increase.
Global regulatory bodies have also assessed the impact of the pandemic and issued new guidance for the management of clinical trials and post-marketing surveillance. Key health authorities, including the US Food and Drug Administration (FDA), European Medicines Agency (EMA), and the UK Medicines and Health Regulatory Authority (MHRA) have released recommendations for stakeholders, providing guidance on the conduct of clinical trials and post-marketing surveillance during the COVID-19 pandemic.
MHRA guidelines convey that efforts should be made to prioritize timely submission of suspected unexpected serious adverse reactions (SUSARs). Sponsors should remain compliant with safety reporting and investigators should continue to collect adverse events from study subjects.
The French Agency (ANSM) guidance has provided flexibility in safety reporting compliance. SUSARs should still be submitted based on existing requirements. However, a two-month delay is allowed for submission of Development Safety Update Reports (DSURs). FDA guidance on conducting clinical trials during COVID-19 recommends that sponsors weigh safety assessment methods, ensuring the safety of trial subjects and avoiding unnecessary contact.
With the new guidance in place, Market Authorization Holders (MAHs) and service providers should be cautious and proactive in defining the pandemic effects to minimize the impact on clinical trials and maintain patient safety.
Pharma companies are assessing and validating tools, automated solutions, and social media surveillance to provide a scientific, patient-centric safety approach, diseases awareness, treatment regimens, real-time tracking and monitoring for clinical trials and adverse events to meet regulatory compliance.
With new regulatory changes, in addition to the global pandemic, the entire life sciences and healthcare space is predicted to grow exponentially in the next few years in terms of clinical trials, and pharmacovigilance & medical devices outsourcing services. This growth is attributed to the rising number of health issues, predominantly in children and the elderly population. This in turn has led to the implementation of advanced healthcare facilities, efficient and effective treatment, and large-scale medical plans proposed by national government bodies to provide better care to patients.
Also, new medicines will launch to treat pandemic diseases and the related risks will push manufacturing units to meet regulatory compliance, this, however, will create opportunities for new business revenue. The COVID-19 crisis has created extraordinary circumstances that require substantial additional resources and an increased availability of vitally important medical devices. The FDA suggests that companies should develop and implement an operations continuity plan to during a pandemic. Healthcare professionals understand the value of reporting. However, there are still challenges during an adverse event and/or incident report. These include failure to recognize the event or incident, lack of time, complex documentation, lengthy reporting procedures, patient confidentiality concerns, fear of blame, employee absenteeism etc. Prompt reporting is pragmatic and arguably, the best method for safety surveillance. Underreporting or a delay in reporting can be catastrophic.
We, at Wipro, have a robust reporting procedure for events and incidents. For the last decade, Wipro has been catering to multiple Medical Device and Pharmaceutical manufacturers to report AE, to be compliant to the regulations. Currently, we are processing 0.5Mn AE cases and 50,000 Regulatory Reports per annum for manufacturers / OEMs. We have a dedicated team working on Regulatory intelligence to keep tabs on new developments in the regulatory world. Our robust system has enabled the submission of regulatory/vigilance reporting in 100 countries. The maturity level of an organization provides a way to characterize its capability and performance.
According to the World Health Organization (WHO), the current year’s global healthcare GDP% expenditure is estimated to increase >10% as compared to 2010. The highest expenditure was recorded in the United States, i.e., 17.07% in 2016 as compared to 14.66% in 2006.
The growing rate of elderly population means a significant increase in the pharmacovigilance outsourcing market too. This generation is highly prone to serious health conditions such as heart problems, diabetes, cancer, paralysis, arthritis, rheumatoid arthritis, seizures, glaucoma, cataracts etc. that requires continuous assessment of adverse events developed from usage of medicines along with ensuring product risk safety and medical treatment.
According to the WHO, the world's elderly population (i.e. older than 60) is estimated to reach 2 Billion by 2050 from 800 million in 2014. Hackers and cyber scammers are taking advantage of the COVID-19 pandemic by sending fraudulent emails and messages through social media that attempt to trick people into clicking on malicious links or opening attachments. Several industries have become victims of such cyberattacks.
At Wipro, we have a strong malware protection and firewall system to safeguard our customers’ information. Our QMS is aligned with ISO 13485, which is globally accepted for medical device manufacturers or service providers. Wipro is a CMMi Level 5, company, and has strong IT systems and processes to safeguard the intent of our customers.
These statistics drive significant demand for old-age medical care and nursing support, along with the provision of homecare facilities. This will drive notable opportunities in the global pharmacovigilance outsourcing market over the forecast period i.e. 2019-2028. Furthermore, for better tracking and monitoring of adverse events across patients globally, the implementation of automation, tools, and technologies is needed for faster assistance to humankind in managing their healthcare conditions.
Multidimensional analytical tools have been implemented in global pharmacovigilance outsourcing services to manage end-to-end periodic product lifecycle reports. These reports outlast CAGR (Compound Annual Growth Rate), BPS analysis, Y-o-Y growth (%) and anticipated cost structure of global business opportunities in healthcare.
Wipro has developed a unique solution called the "PV Automation Service Platform". It helps to achieve a complete, correct, and compliant output through a Global Delivery Model, wherein pharmacovigilance operations teams can ensure clinical and compliance corrections of cases.
Our solution leverages Intelligent Automation driven by RPA, Artificial Intelligence, a proprietary workflow engine, and operations management systems that enable you to customize processes and metrics to the client’s specifications. Our framework tracks the process, monitors metrics, and extracts meaningful reports.
Wipro is focused on continuous improvement and is built to pivot and respond to opportunity and change. As a global leader in the life sciences and health sector, Wipro has developed several innovative tools to bring automation such as voice to text, e-mail, smart scripts etc. to support such enquiries and legal complaints. Wipro HOLMES enables automation across industries to drive digital transformation for various business functions. During the current pandemic situation, Wipro enabled ~95% work from home, with stringent information security processes in place. Our stability provides a platform for agility and innovation.
Wipro leverages innovations and tools to reduce operational efforts. Our key drivers are:
- Achieve flexibility in Pharmacovigilance solution to a more easy-to-scale, outsourced, SLA-driven, service-oriented model
- Enable the quality and efficiency of PV operations to deliver in a secure, proficient manner
- Achieve risk-free seamless implementation of the new safety solution
- Alleviate the bandwidth of our customer’s existing staff on standard PV operations and implementation management
- Unique Factory-Based Operational Model to strike a balance between efficiency, compliance, quality & effectiveness
- Automation-driven operations culture
- Experienced resources and ready infrastructure
- Diverse BPO Experience in ICSR processing received from various sources viz. spontaneous, clinical trial, literature, solicited, social media etc. for drugs, OTCs & medical devices
- Robust Experience on Safety Database (Argus, ARISg)
- Business Excellence team (LEAN, Six Sigma) for continuous PV process improvement
Healthy partnership with a long-term, value-driven approach to pharmacovigilance
Current pharmacovigilance and clinical trials services have been disrupted by enforced lockdowns, this has pushed businesses to adopt new working models with virtual support by implementation of tools, technology, and automation. To analyze the data received from various sources, sponsors are highly dependent on synergy between traditional analytics and validated clinical data to provide faster and better treatment to patients, ensuring safe drug usage.
Travel restrictions brought on by the pandemic have also resulted in due diligence activities. Manufacturers can approach Wipro for regulatory compliance such as implementation of EU MDR or EU IVDR, regulatory / vigilance reporting, medical information contact center, and training of healthcare professionals.
The pandemic situation will several challenges as well as opportunities for the global pharma and life sciences industry, in the form of data complexities, regulatory compliance, and stringent timelines. The pharmacovigilance market survey and implementation of automation and tools will help global clients in timely reviews on their product risks, safety and compliance, while simultaneously helping them understand the risks associated with the early phase of drug development. This will go a long way toward assisting them in serving humankind with timely tracking and monitoring of drug effects.