In the digital world, the engagement of a complete collaborative compliance solution is now essential to accelerating process efficiency through review to release, and ultimately for product commercialization.
Inefficiency through medical/promotional content review and approval within the life sciences has a dramatic impact on time to market for pharmaceutical and medical device companies that are already faced with considerable barriers throughout their product development lifecycles.
Addressing and streamlining medical and legal review challenges in the digital age can significantly improve knowledge sharing, both internally and in collaborative partnerships and dramatically reduce a product’s time to market.
Promotional material developed within the life sciences is subject to strict regulatory guidance, which must be taken into consideration from the outset, i.e. the brand concept stage, for optimum transition through review and publishing cycles. The inclusion of appropriate stakeholders and their engagement is vital. Failure to consider medical, marketing, and legal implications within an original publication plan and marketing strategy can bear both financial and legal implications following publication.
It is therefore critical during concept development and briefing stages that any pharmaceutical or medical device company consider all legal and medical implications within a claims document. This should be considered carefully before any brief is provided to the medical communications partner.
Simplifying Compliance Via The Cloud
One solution to managing the compliance of the briefing documentation is to streamline all information materials, written documents and notation in a secure cloud-based solution. Working in open partnership, both marketing and medical legal review (MLR) professionals can then clearly consider their claim and product USPs against the requirements of the regulatory landscape.
Once a fully compliant brief has been compiled, ensuring all claims meet regulatory standards, the company will begin to engage with a medical communications partner on all content creation, referencing and creative design aspects of the medical/promotional documentation.
Here again, the adherence to key messaging and evidence supported claims is crucial as inaccuracies can incur stark legal penalties and challenges from competitors or public persons. The use of a well-managed referencing library is an essential tool for maintaining quality and consistency in this regard, and a cloud-based solution is favorable for allowing both parties to access and evaluate existing and new reference materials.
In the evolving digital environment where branding takes many forms, it is essential for any creative designer to be able to access all notations and summarized aesthetic preferences within the design interface itself, identifying the requirements of the original brief and any particular regional or legal constraints while the design work is completed.
Within the review cycles, medical/promotional documentation is most at risk of being subject to quality control mistakes, time delays and ultimately legal misguidance if not properly managed. Here quality assurance, consistency, and further review will be hindered if access to information and previous annotations are inhibited.
Optimizing the MLR Process
MLR professionals will review a significant number of materials on a day-to-day basis, and as pharmaceutical and medical device companies continue to consolidate and/or cut headcount, their incapacity to process review materials in a timely fashion becomes a great constraint on process efficiency.
Modern multichannel and digital publishing channels, especially those which fall within the digital and social media realm, require more detailed scrutiny within the review stages, again pushing back the time on delivery to market. The solution: a workflow tool allowing accurate compliance review of rich media and digital content for publication via this method, tailored to the companies specific outreach preferences. By mapping out a regulatory process for each channel, a company can structure content management efficiently throughout their organization.
Once any medical/promotional document has been through full review, thoroughly inspected for compliance accuracy, and finally approved for distribution, materials can then be published and stored for reuse.
Another industry problem is when materials are siloed and underused in a privately archived single marketing unit within a multinational life science company or indeed, their medical communication partner. The embedded costs associated with that medical/promotional material is then lost, when it could easily be repurposed through distribution and sharing within other localities/affiliates.
A cross-referencing and digital asset management tool allows previously used promotional documentation to be revaluated and reclassified for publication in different countries, avoiding the costly initial stages of concept development, creation and review and facilitating brand alignment. This is where the value in employing an effective digital asset management solution becomes apparent enabling materials to be centrally accessed from any geography and reused effectively and efficiently.
Underpinning the Customer Experience
In the digital world, the engagement of a complete collaborative compliance solution is now essential as a means of accelerating process efficiency through review to release, and ultimately of product commercialization. The effectiveness of compliance and corporate integrity management is integral not only to the life-science companies’ customer experience, but its reputation and relationship with all its stakeholders. The complexities that exist within the content compliance space in the life sciences are indeed challenging and should be managed with appropriate caution, given the implications of misappropriation.
Zinc Ahead is the world leading provider of compliance solutions to the life sciences industry. Committed to innovation and product excellence, its flagship product Zinc MAPS has transformed compliance processes in over 170 life sciences companies across the globe. For more information, visit zinc-ahead.com.
