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Promotional and Medical Review

Full-thickness solution for simplified and faster material review and approval of promotional and non-promotional assets
Introduction

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

  • Damaged reputation

  • 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 need for Strategic PMR Management

Current MLR Reality

Current MLR Reality

Our experience of working with the some of the world's largest pharmaceutical companies informs us that -

Medical Affairs teams are looking to continually improve the efficiency and effectivity of the MLR processes. Specifically, they are looking to –

  • 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 PMR Offering

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:

  • Language check

  • Proofreading

  • 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

Augmenting Technology with Medical Expertise

Augmenting Technology with Medical Expertise

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.

Key Outcomes

Track Record

Track Record
Key Performance Indicators

We continually track the following key performance indicators and improve our offerings to keep improving on these indicators –

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