Higher complexity of regulations and global reach of external medical communications means that compliance matters today more than ever with more content, more stakeholders, and more channels.
While companies have consolidated content development capacity, medical review capacity has not always kept pace. The consequences of compliance oversights are obvious:
Legal exposure and financial penalties
Enforcement of stringent regulations
We help scale your medical and regulatory review capacity to reduce risk of exposure and meet company diligence requirements for all types of content and communication channels.
The successful adoption of digital marketing channels such as interactive websites, i-Details, e-mails, social media and search engine optimization have enabled pharmaceutical companies to effectively and efficiently communicate with their customers. The commoditization of advanced analytical techniques such as web analytics, app analytics, social media analytics, advertising analytics, audience analytics and big-data analytics has enabled the companies to better understand customer preferences and behavior. This has led to finer segmentation of customers, with the segment sizes getting smaller. As the companies understand these segments better, they are able to use this knowledge to personalize the content to target these segments. This has led to explosion in volumes of marketing and scientific exchange material.
The medical affairs team needs to be able to comprehensively review these ever-increasing volumes of content, while improving on the accuracy of the content and ensuring that 100% compliance is maintained.
Our experience of working with the some of the world's largest pharmaceutical companies informs us that -
Improve accuracy of the content
Ensure 100% compliance by following regulatory guidelines and by filing regulatory information on time
Improve the speed to market, maximizing the chances of marketing campaigns to succeed
Improve productivity by ensuring "right first time" reviews, improving stake-holder collaboration and ensuring actionable feedback is provided early to the agencies that create the content
The Medical Affairs teams are also looking toward modern technologies such as Robotic Process Automation, Artificial Intelligence, Machine Learning, Deep Learning, Natural Language Processing and Natural Language Generation to provide increased productivity and scale to further improve operational excellence.
Indegene is a full-thickness provider of accurate, simplified and faster material review and approval solutions
The Indegene PMR offering is designed to be flexible and modular in nature. We understand that the needs of each customer may vary and strive to provide offerings that are personalized to the needs of each customer. We have been able to use this model in a variety of use-cases to suit the needs of our customers. You could know more by reading our highlighted case studies. Broadly, the different types of engagements that we have done with our customers include –
Provide one or more of Technical, Editorial and Regulatory reviews with the customer managing and controlling the operations
Provide one or more of Technical, Editorial and Regulatory reviews,
while collaborating with other service
providers/agencies of record that the customer already works with
Manage and Control end-to-end editorial and medical reviews, while the customer manages the regulatory and legal review processes
Manage and Control end-to-end editorial, medical and regulatory reviews, while the customer manages the legal review processes
Our comprehensive editorial review services span all stages of material development in the pharmaceutical industry context and includes print and digital assets. Our services include:
Style guide conformance and plagiarism check
Medical review services leverage our core strength of medical and scientifically trained staff. Our medical review services ensure that scientific statements and promotional claims are substantiated by high-quality evidence. Our medical reviewers ensure:
Substantiation of promotional and non-promotional statements by high quality evidence
Factual correctness of data which is adapted into claims
Our regulatory review services ensure that medical statements or claims are appropriate against national guidelines which regulate external communication of scientific and promotional content. We provide:
Pre-campaign advisory services and facilitation of communication with local competent authorities for opinion
In-line review of materials to ensure fair representation of scientific information and appropriate use and audience
Qualified person or signatory services
At Indegene, we believe that modern technologies are the key to improving accuracy, increasing productivity and providing scale to the Medical Affairs teams. We have significant expertise in modern technologies such as Machine Learning, Deep Learning, Predictive Algorithms, Natural Language Processing and Natural Language Generation. We also have deep medical expertise, as evidenced by the high representation of subject matter experts (PhD, MD, PharmD) that work with us. We leverage these strengths of ours to contextualize modern technologies with deep medical expertise, enabling our solutions to cater to the specific nuances that the medical affairs team deals with on a regular basis.
We have seen significant reduction in time to market for promotional and scientific materials and significant increase in productivity of the MLR function as a result of deploying our technology solutions.
We continually track the following key performance indicators and improve our offerings to keep improving on these indicators –
Time to Market
We consistently have been able to provide comprehensive review services with an error rate of less than 0.5%. Our singular focus is on getting our reviews "right first time". Our medical review services over a period of close to 7 years have ensured that every document that has been published and has no information that cannot be scientifically substantiated. We have been able to reduce the editorial error rates by over 50%.
We have been able to reduce the time to market for promotional and scientific material by about 30% as a result of:
Implementing a Submission Validation process, which captures almost all of the submission issues at the time of the first review
Operationalizing best practices
Deploying a hybrid model that includes onsite and offshore specialists for round-the-clock coverage
We have been able to boost the productivity of the review processes of our customers by over 50%. We have been able to achieve this as a result of the following –
Providing continuous and nuanced training to our review specialists. We also extend these trainings to our customers
Hiring the best subject matter experts. Over 40% of our employees are PhDs/MDs/PharmDs, with most of our other employees having significant pharmaceutical industry knowledge and experience.
Centralizing the operations of Editorial, Medical and Regulatory review processes, improving the effectiveness and efficiency of interactions and knowledge retention among the editorial, medical and regulatory review teams
Contextualizing modern technologies such as Robotic Process Automation, Artificial Intelligence, Machine Learning, Deep Learning, Natural Language Processing and Natural Language Generation with our deep medical expertise to automate an increasingly significant portion of the review processes
We have maintained a track record of 100% compliance on all our engagements. Our specialists have the knowledge of regulatory guidelines, with a special focus on FDA/OPDP, MHRA/ABPI, EPA/EFPIA and other local European national regulations. Our specialists are regularly and continuously trained on ever changing regulatory policies. We also engage closely with key personnel that are or have been involved in constituting regulatory guidelines
We have been able to reduce the cost of MLR reviews by about 30%-40% for our customers. Some of the key contributors to the reduction in cost are –
Right first time reviews reducing the cost of rework
High-quality pre-medical reviews that reduces the work-load on the medical review team
Implementation of operational best practices that we have learnt over the years with multiple customers across the globe
Hybrid operational model with most of the editorial review and pre-medical review work executed by offshore specialists