Content Management System
The pharmaceutical industry is a highly regulated market, and deviations from set guidelines can lead to non-compliance and damage to a company's reputation. The industry shares a significant amount of content, including medical, marketing, and regulatory information, with respective stakeholders. Managing content with accuracy is a challenging task; however, with the help of a Content Management System (CMS), the herculean task of content compliance can be strategically implemented, reducing risk and enabling the timely launch of life-saving products.
CMS Challenges: Current Perspective
1. Manual Process:
Manual review and approval systems can be time- consuming and carry the risk of human errors, which could delay drug registration or entry into new markets.
2. Regulatory Compliance:
The greatest challenge is compliance with regulatory bodies such as the FDA, EMA, and CDSCO, as non-compliance can result in penalties, product recalls, and damage to a company's brand.
3. Content Volume:
Every new research, existing clinical research, updates in ongoing research, labelling, marketing brochures, patient leaflets, and so on, needs to be updated cyclically based on the frequency of changes.
4. Accuracy:
The lack of a CMS may present accuracy challenges due to the manual process of content handling by multiple stakeholders. Content needs to be accurate across multiple channels; otherwise, it will lead to non- compliance.
5. Version Control:
Maintaining every version change of a document needs to be managed; otherwise, multiple versions of documents will lose track of authenticity and the latest content changes.
6. Audit Friendly:
Content should be traceable for changes, approvals, and dissemination across all channels to ensure accuracy.
7. Content Duplication:
If departments are working in silos, it will pose a threat of duplication and inaccuracy in the content.
8. Data Security:
It is of prime importance to protect sensitive clinical or patient data, and with manual handling, this is impossible to achieve.
9. Approval Delays:
A manual process of document reviewing and correction, combined with a lack of visibility among multiple stakeholders, can delay the approval process and lead to errors.
Addressing Challenges via a Robust CMS System
A well-implemented CMS strategy will tackle conventional challenges and help organizations engage through centralized, secure, and automated platforms while working with all types of content.
Streamlining Content Workflows
1. Streamlining Medical, Marketing, and Regulatory Content Workflows
Medical content includes clinical trial data, scientific data, real-world evidence, adverse event reports, educational materials, etc. A centralized repository for all medical information will help ensure consistency. A CMS streamlines and speeds up the medical, legal, and regulatory (MLR) approval process. It also helps in the reuse of approved content on different platforms and its distribution. It also tracks content performance and provides data-driven insights. A CMS supports regulatory compliance checks for drug submissions, labelling, or safety documents, etc.
CMS Best Practices
1. Modular Content:
A Content Management System is designed to solve problems related to version control, duplication, and approval delays. In this approach, content is broken down into small, reusable modules. Each module has its version history, and updates to a single module will automatically propagate to all documents referring to it. Content created and approved once, then reused multiple times, can reduce duplication. This will help in faster approvals when modules are pre-approved. It ensures consistency across all channels and marketing materials.
2. Metadata Tagging
It tackles the issue of searchability. Metadata means "data about data." It involves creating descriptive tags for every piece of content. This, in turn, improves searchability and the organization of content based on metadata. Content can be delivered based on user role and location, ensuring relevant information can be accessed by the right user.
3. Automated Approval Workflows
They simplify workflows, remove manual routing, and speed up the approval process. The approval process is digitally recorded and can be used for audit trails for regulatory compliance. It reduces errors associated with manual routing. It is a single source of documents. All approved documents can be accessed from one location. It ensures that content adheres to regulatory guidelines. It tracks changes in the content and ensures the latest approved versions are being used.
Omnichannel Publishing
Omnichannel Publishing is a Key CMS Features Pharma Companies Should Prioritize for Compliant, Efficient Content Delivery. Omnichannel publishing ensures the delivery of consistent and compliant content across all touchpoints in a customer's journey. It ensures seamless integration across channels, enabling them to work together for a unified experience.
Key CMS features for compliant, efficient omnichannel content delivery
- -Modular Content Management allows content to be broken down into reusable, granular modules. It guarantees consistency, enhances efficiency, and ensures compliance with regulatory standards.
- -Workflow and Approval Management automates the content review and approval process, including for MLR Teams.
- -Version control and audit trails are automatically recorded to support regulatory compliance.
- -A CMS delivers consistent messaging and a unified brand experience across all channels.
- -It manages content in multiple languages, enabling pharma companies to communicate with diverse audiences while ensuring compliance with local regulatory authorities.
- -Ensuring data integrity and confidentiality is essential for regulatory compliance. Pharma companies can build a CMS that supports omnichannel and also adheres to compliance, accuracy, and efficiency. With AI-empowered Keacyte's CMS module, medical content tailored by specialty and product can be easily managed across all channels. Authenticated users get on- demand access to approved material. Content views, time spent, and engagement with healthcare professionals (HCPs) can be tracked. It enforces compliance with approval workflows and maintains role-based access control. It keeps teams aligned with real-time content updates across channels. It supports multiple formats, including interactive detailing assets. It optimizes content strategy with real-time usage analytics.