What is pharmacovigilance?
Pharmacovigilance also known as drug safety, refers to the detection, assessment, understanding, and prevention of adverse effects or any other possible drug-related problem. Here ‘adverse effects’ refer to any untoward medical occurrence which happens to either a patient or a subject in a clinical investigation when a pharmaceutical product has been given to them. This includes any signs which are unfavorable and unexpected for the patient or subject, including any abnormal laboratory findings. Information received via pharmacovigilance agreements (PVAs) from patients and healthcare providers, as well as other sources such as the medical literature, plays a critical role in providing the necessary information for undertaking pharmacovigilance. In fact, in order to market or to test a pharmaceutical product, most countries have mandated the requirement for adverse event data received by the license holder (usually a pharmaceutical company). This data is required to be submitted to the local drug regulatory authority. Let’s examine some of the key importance of pharmacovigilance in healthcare:
Importance of pharmacovigilance
Clinical trial regulation
One of the importance of pharmacovigilance is that it facilitates clinical trial regulation. The recent years have witnessed a skyrocketing increase in clinical trials in the United States alone. Furthermore, the increase in the complexity of clinical trials is leaving regulators with several challenges to face. Clinical trials are mostly contracted to clinical research organizations and patient recruitment agencies. These agencies act as intermediaries between the sponsors of the study, the investigators, and the patients. The importance of pharmacovigilance can also be established from the fact that it enables improved and more rapid changes in labeling or even withdrawal of a new drug from the market. Furthermore, a standardized reporting system for safety concerns arising during clinical trials can be established. Pharmacovigilance also plays a vital role in ensuring patient safety and strict compliance with prescribed regulatory requirements that would substantially improve standards of clinical trials.
Monitoring post-marketing safety
A part of the process of evaluating drug safety should ideally take place in the post-marketing phase. Safety monitoring is not only limited to the cases of new drugs or significant therapeutic advances. The importance of pharmacovigilance is notable in the introduction of generic medicines, and in the review of the safety profile of older medicines already available, where new safety issues may have arisen. Spontaneous reporting is a cornerstone of pharmacovigilance in the regulatory environment is indispensable for signal detection. The need for more active surveillance has also become increasingly clear in recent years. Without reliable and authentic information on utilization and the extent of consumption, spontaneous reports do not make it possible to determine the frequency of an ADR related to a product or its safety.
There has been an increased spending in direct to consumer advertising by pharmaceutical manufacturers. This results in national regulations on advertising to become ineffective. Several websites now enable buying and selling of prescription drugs such as benzodiazepines without controls. These developments in communication have a significant impact on the safety of medicine. Such issues suggest the need for more thorough monitoring of drug safety and scrutiny of advertising. This highlights the importance of pharmacovigilance.
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What the Client Wanted
Leverage data mining techniques to predict future outcomes by identifying incongruities, data correlations, and patterns within huge sets of data in the traditional Chinese medicine segment.
A leading traditional Chinese medicine (TCM) manufacturing firm, wanted to help their patients achieve and maintain health by developing precise remedies to tackle their health issues. The staggering amount of unstructured data related to lifestyle disorders and other chronic diseases posed major challenges that hampered their R&D process.
To unearth insights using the right data mining techniques, the traditional Chinese medicine manufacturing firm approached Quantzig to leverage its expertise and devise appropriate solutions to help their customers.
Traditional Chinese Medicine Market Overview
Traditional Chinese medicine is an ancient field of medicine based on the principles of Daoism, which states that everything in the universe is interrelated. Thousands of years of observation and practice resulted in the development of traditional Chinese medicine, which follows a unique strategy to understand the functions of internal organs and physiological processes. Traditional Chinese medicine is a very complex and complicated field of the medical system that aims at promoting health through diet and exercise. It also focuses on treating illnesses using herbs, acupuncture, and Qigong.
Challenges facing the Traditional Chinese Medicine Market
- Authentication issues: Traditional Chinese Medicine (TCM) is winning supporters across the world, which makes it necessary for players in this filed to validate the safety and quality of their medicinal products. A proper authentication process along with the use of data mining techniques can help ensure that the products are safe from contaminants. However, the recently formed Chinese Medicine Association of Suppliers (CMAS) in the UK plays a key role in authentication.
- Difficulty in creating an appropriate placebo: A major challenge for traditional Chinese medicine practitioners revolves around the difficulty in developing appropriate placebos for multiple-herb based decoctions. This is because it is technically challenging to produce an indistinguishable placebo in the form of decoction for a multiple-herb formulation.
About the Client
One of the largest manufacturers of premium traditional Chinese medicine. The client is a global leader in scientific research and production of Chinese Granule Herbs, with their sales network spread across 30 countries globally. It is also notable that the company owns 30 patents for herbal formulation invention and several other intellectual property rights of key technologies used in production.
Owing to the challenges they faced in drug discovery, the client wanted to implement efficient data mining techniques to discover data patterns that help improve the quality of drug discovery and drug delivery methods. The traditional Chinese medicine firm wanted to sift through the repetitive noise in their data to gain an understanding and make use of relevant factors and assess likely outcomes.
Data Mining Engagement Summary
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Implementation of data mining techniques helped the traditional Chinese medicine manufacturer to build a successful predictive model to predict future outcomes of their medicinal formulations. It also helped them find answers to essential analytical questions such as – Which formulations are likely to be retained? How to ensure effectiveness and efficiency with optimal resource allocation? What factors after the drug discovery process?
Insights on data mining techniques
Organizations today have access to huge volumes of information that is gathered from all kinds of sources across the industry. However, the unanswered question here is – How can you use this data to generate insights that are required to drive business value? This is where ‘Data Mining Techniques’ contribute in a big way. Data mining techniques play a key role in helping organizations predict future trends and act accordingly to carve out a niche for themselves in the market.
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Companies in the pharma industry have been growing exponentially over the last couple of years. In order to cope up with these changing market dynamics, pharma companies must reassess strategic direction, anticipate and absorb change, and move with deliberate speed. In this new era, top pharma companies will have to become more proactive to meet the demands of a wide swath of consumers. The sale of goods will undoubtedly be a priority, but pharma companies will also have to emphasize greatly on delivering positive results, which includes the well-being and optimal management of illness among targeted groups in the new health economy. Here are some of the pharmaceutical industry trends that you need to certainly keep track of this year:
Technology will positively impact pharma companies in the years to come. Pharmaceutical industry trends such as e-services have begun to automate processes across the patient journey, often resulting in improved speed and customer experience. In fact, e-services have proved to be a major platform for the growth of companies in the pharma industry. Going forward, brand teams should have technology conversations as a part of every launch strategy and specific conversations about opportunities to converge e-processes in the name of better customer experiences.
Factors such as the restructuring of the U.S. healthcare delivery system, competitive landscape of dynamic costs, and the stringent regulatory demands are challenging the pharmaceutical industry. Differentiation has become one of the key aspects of focus for top pharma companies. As such, changing the way in which players in this industry reach out to and extend patient care is one of the top pharmaceutical industry trends to watch out for this year. By using a relatively new technique known as the blue ocean strategy, top pharma companies are revamping the manner they approach their patient access strategies and product launch. Blue ocean strategy suggests that lasting success comes not from battling competitors but from creating “blue oceans” of uncontested market space ripe for growth.
Innovation will also be driven by an increase in collaboration across top pharma companies in the sector. To thrive in the ever-increasing competition in the market, pharma companies will have to work together to develop new and innovative products, services, and solutions. These companies will also greatly benefit from sharing each other’s skills and expertise. Recent collaboration between AbbVie, a research-based biopharmaceutical company, and the Google-backed life sciences firm Calico is an instance of collaboration being one of the noteworthy pharmaceutical industry trends in the recent times. Calico’s technical expertise was used to establish a new R&D facility, and AbbVie used its commercial expertise and scientific and clinical development support and to bring discoveries to market. In this manner, the two companies hope to discover, develop, and market new therapies for patients with age-related diseases and cancer.
Frequent product launch
Nearly 200 new drugs are expected to be introduced into the market in the next five years. Which means that this will be a continuation of the second wave of innovation, similar to levels seen in the mid-2000s. Furthermore, the number of medicines receiving the FDA’s Breakthrough Therapy Designation is skyrocketing. This is contributing to an acceleration of approvals. However, the global availability of these new medicines to patients varies significantly depending upon the country and disease.
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LONDON: Quantzig, a global analytics services provider, has announced the completion of their latest inventory optimization for a pharmaceutical retailing client. The pharmaceutical retailing industry is concerned with businesses that engage in retailing prescription drugs or patent medicines, toiletries or cosmetics, and prescription medicine dispensing. The pharmaceutical retailing industry is expected to show a significant growth trend in the years to come, as the average age of the consumer for this sector is increasing rapidly. With the rise in the need of the aging population for enhanced healthcare and prescription, there is a constant growth in the customer base of pharmaceutical retailing.
“Inventory optimization solutions can help businesses eliminate out-of-stock situations, improve efficiency, and curtail inventory costs. Furthermore, with the help of the solution, companies can gain optimized service levels for different product categories. Additionally, companies can better define processes and monitor and manage high-risk categories.” says an expert at Quantzig.
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The solution offered helped the pharmaceutical retailing client devise advanced processing capabilities to estimate product redeployment between stores and adopt a tiered strategy for providing services. The client was also able to make changes to staffing, fulfillment, and delivery processes to centralize products and inventories with the help of the solution provided.
Additional Benefits of the Inventory Optimization Solution
- Improve working capital efficiency and reducing inventory while maintaining service levels
- Reduce inventory costs by carrying the right product at the right time to the right place.
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Tips to Improve Salesforce Effectiveness for Pharma Companies
For long, pharma companies have relied on empirical data to identify patterns, test theories and understand the efficacy of treatments. Innovations, when it comes to launching new products , is a key strategy for pharma companies to maintain their operating buffers. But improperly designed clinical trials, unsuitable patient population, and lack of competitive differentiation are some of the key factors fueling drug failures pre- and post-launch. Advanced analytics has the power to transform the growth strategies of pharma companies. By mapping patient trends to identify target markets, narrowing down on test sites with high patient availability , and to highlight gaps in the efficacy and safety of current drugs, advanced analytics can significantly accelerate drug discovery and development. Pharma companies benefit from adopting advanced analytics for their sales and marketing functions. Analytics tools can be used by players in this sector to improve the sales force effectiveness. Sales executives are adopting digital communication tools to share information with physicians, and also using analytics to develop tailored messages and more meaningful interactions. Here are four ways in which pharma companies are using advanced analytics to drive innovation and value:
Drug discovery and development
With the help of advanced analytics, pharma companies can intelligently search vast data sets of patents, scientific publications, and clinical trials data to help accelerate the discovery of new drugs by enabling researchers to examine previous results of tests. Analytics techniques such as predictive analytics help players in the pharma industry to gain the relevant information and also gain insight into the avenues are likely to yield the best results.
Marketing and sales performance
Pharma companies can quickly identify the new, niche, and underserved markets by using advanced analytics to interpret information from various sources such as social media, demographics, electronic medical records, and other sources of data. Furthermore, by analyzing the effectiveness of sales efforts and recording the feedback received by the sales team during client visits and using it effectively can help pharmaceutical companies gain an edge on their competition.
Better safety and risk management
Data gathered and analyzed from a range of sources including social media, customer feedback, and Google searches can act as an early warning signals for pharma companies about product safety issues. Furthermore, pharma companies can think of ways in which this type of unstructured data can be used more efficiently. Players in this industry can undertake advanced analytics techniques like web scraping, where they can draw down lots of various hits or posts from the Internet and then analyze that data. This will help companies to see a larger picture of the public sentiment towards the brand and its products.
Target specific patient population
A vast array of patient data are available than ever before to pharma companies from medical sensor data (a device that can be worn and track physical changes in an individual during treatment) and electronic health records. Pharmaceutical companies can dig into the causes of specific conditions and realize that one size indeed does not fit all. Within any disease or condition, different patients will respond differently to treatments. Data from these various sources can allow drug companies to spot trends and patterns that will enable them to come up with more targeted medications for patients that share common features.
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LONDON: Quantzig, a global analytics services provider, has recently completed their latest customer segmentation solution for a pharmaceutics products client. As the access to healthcare is increasing, prominent businesses are planning to manage healthcare funding and take effective measures to reduce the price gaps between local and international brands. Additionally, factors such as the rise of aging population, urbanization, changing lifestyles, and increasing incidences of chronic diseases are expected to drive the growth of the pharmaceutical products space.
“Customer segmentation helps pharmaceutical products suppliers to divide their customer base into sub-segments to tailor their marketing efforts adequately. Furthermore, customer segmentation also helps businesses gain a deeper understanding of their customers’ preferences and needs to maximize cross-selling opportunities..” says an industry expert from Quantzig.
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The customer segmentation solution helped the pharmaceutical products client to identify methods to improve product and service opportunities and establish better relationships with their customers. Also, the pharmaceutical products supplier was able to predict the most profitable customer segments and allocate their capital resources efficiently.
Additional Benefits of Customer Segmentation Solution
- Differentiate customers based on their economic value
- Identify the most lucrative opportunities and consequently increase revenues on investment.
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