Kunwar B. Kishore Arora, Global Chief Operating Officer
The massive explosion in data has extensively affected the pharmaceuticals industry to accelerate the operations, tailor the therapies, and enhance patient care. Due to the valuable insights available from a vast amount of data, pharma companies are coming out with better/blockbuster drugs leading to a significant growth being registered in total approvals for rare and specialty diseases. In a typical clinical setup, drugs may appear to be safe and well-tolerated by the subjects. However, what truly matters is the drugs’ efficacy and safety in the real world especially on vulnerable groups such as pregnant and lactating women, young children, and the elderly. To ensure this, there are various regulatory authorities in place to keep a vigil on drugs across the lifecycle. As the regulatory guidelines are becoming tighter, the regulators are becoming more risk-averse. As a result, the pharma organizations need to ensure that their product coming to the market or the approved one stays relevant by providing the necessary information and data transparency to the regulators. Hence, these organizations harmonize their pharmacovigilance to meet the compliances across the globe and ensure that patient safety comes first.
Set against this backdrop, is APCER Life Sciences; the services and consulting firm that is committed to helping pharma organizations (pharmaceutical, biologics, vaccines, devices, OTC and consumer healthcare product lines) to deliver compliant products that meet the industry’s regulatory requirements. “Our service comes with an assurance and deep domain knowledge that ensures our clients’ product will always meet the compliance requirement anywhere around the world,” mentions Kunwar B. Kishore Arora, Global Chief Operating Officer, APCER Life Sciences.
To meet the growing requirement of robust pharmacovigilance services, APCER has streamlined and well-documented processes in place that they have broadly characterized in few areas. First and foremost, to manage the ‘medical information,’ the company has three 24x7 Integrated Response Centers (IRC) across the globe for answering the medical inquiries, handling product complaints, adverse events, and capability to disseminate requisite information in 30+ languages. IRC is staffed with skilled healthcare professionals to receive and respond to calls, emails, and faxes concerning the information or complaint about medical products. In addition, IRC staff are medically qualified in developing and delivering standard and customized responses to medical inquiries as received. APCER has requisite technology platforms (industry-leading MedInfo system) to process this information; they also work on clients’ systems to integrate with their processes for the effective resolution of queries.
Furthermore, APCER’s client-focused teams receive and triage serious and non-serious cases, performing detailed case entry and follow-up, quality and medical reviews, as well as narrative writing, to enable on-time reporting. Writing, in fact, is something that APCER has deep expertise in, be it medical, clinical, regulatory writing or benefit/risk reports, periodic safety reports, or web synopses, they have proficient team to handle it. Besides, the company ensures that periodic reports, risk assessment documents, safety summary updates, and more are aggregated in a proper format and are submitted to the relevant regulatory authorities within compliant timelines.
Our vast experience in supporting 45+ regulatory inspections till date, prominence of 15 percent physicians within the company, and having 100 percent of operations staff as Health Care Professionals (HCPs) makes us the preferred choice for pharma companies who are looking for pre / post-marketing compliance and safety solutions
After that, they also perform ongoing signal evaluation and management for clinical and marketed products, and literature search wherein APCER searches for all types of products, using standard terms, triage analysis, relevant processing, and more. “Our vast experience in supporting 45+ regulatory inspections till date, prominence of 15 percent physicians within the company and having 100 percent of operations staff as Health Care Professionals (HCPs) makes us the preferred choice for pharma companies who are looking for pre /post-marketing compliance and safety solutions,” says Arora.
Established in 2007, APCER has catered to many needs of its clients and continuously delivered business value, compliance solutions, and inspection readiness. In one such instance, a top 20 pharmaceutical company with hundreds of trials and marketed products worldwide realized that its documentation for clinical and post-marketing safety was yielding inconsistent narrative and medical assessments. The company, taking a different route, moved from multiple CROs and regional case processing units in Asia, Europe, and North America to a single worldwide center of excellence. The goal of the leadership team was to improve signal detection and benefit-risk management across all its products by raising data quality and causality assessment standards. Besides, the team was also looking to eliminate process backlogs of literature and other nonserious cases. Understanding the need to collaborate with a specialized service provider, the name APCER was highly recommended at the executive level owing to the high quality of work delivered at other large pharmaceutical companies. Post collaborating with APCER, the pharma company was able to maximize quality and compliance while reducing the cost by 30-40 percent, stabilize safety operations, and finally eliminate backlogs.
In a nutshell, APCER owing to its commitment to providing end-to-end compliance service works in conjunction with every client on the strategic planning for regulatory submission with various authorities in different regions. “We lay a strong foundation by understanding the clients’ processes first and then decide on the best pharmacovigilance strategy that will work for them for specific markets or across the globe,” mentions Arora. Additionally, they keep track of regulatory changes and update the client’s product applications if required. APCER also supports filling of documents throughout the product lifecycle, from the NDA, ANDA, IND, CTD, and eCTD, to clinical overviews, periodic and annual reports.
However, the competitive edge of APCER does not lie in how many services they offer. Instead, it lies in how they have interwoven a variety of service environments such as safety, medical, and regulatory operations with technology and offer an agile and transparent activity-based engagement model to customers. Going forward, they are betting big on enhancing their technology adoption. “We are building the capabilities around artificial intelligence along with some of our strategic partners by writing a sophisticated algorithm to automate several manual processes and adopt next-generation technologies to leverage the new gold in the form of data,” mentions Arora. This unique value proposition does not stop just with the technological aspect APCER strengthens its roots by inculcating best practices in their standard day-today operations as well.