The following output is based on the discussion and consensus of the expert panel for the process of creating and localizing GRDs. Table 2 summarizes the best practice statements.

Table 2 Best practices for GRDs3.1 Structure of Work

It is important to understand that organizational differences will impact the interaction between global and local medical information teams. In general, GRDs are documents based on published data and data on file (DOF), such as the core data sheet, manufacturing data, data from regulatory filings (e.g., common technical document), and clinical study reports. An organization’s internal structure affects how GRDs are primarily developed. Using a dedicated global medical information department is one approach. Alternatively, a local medical information group may take on this global function. For clarity, this article refers to GRD creation as a global medical information function. Figure 1 summarizes the structure of work between global and local medical information teams. One key lesson is to balance between global consistency and local adaptability.

Fig. 1

Structure of work between global and local medical information teams. *For example: if the only change was addition of local label, a local review may not be needed. GRD global response document, HCP healthcare professionals, SRD scientific response document

Global response documents may range from a tailored document answering a specific question to an extensive document, encompassing multiple topics providing a broader perspective. The local medical information group may tailor extensive GRD documents to answer specific questions. Global response documents can also be written in a label agnostic manner, with only the cover letter containing the local label's language, allowing the local team to use the unmodified GRD. Global response documents do not cover local matters such as pricing and reimbursement.

The creation of GRDs often aligns around the time of regulatory filing for approval. Global medical information develops a topic list for GRDs addressing anticipated frequently asked questions based on product type, indication, clinical study results, draft labeling, and competitive landscape. Global response documents include a broad range of topics from storage and stability to pharmacodynamics and pharmacokinetics to efficacy and safety. As the focus of GRD creation is anticipatory, unanswered time-sensitive questions from clinicians are handled as a custom response either by the local team or escalated to global. Global medical information may closely collaborate with other global teams during writing (such as medical directors, medical communications, pharmacovigilance, legal/compliance, regulatory affairs). Global medical information is often on a rapid response team to address real-time questions after the first product launch to fill gaps within the GRD library.

3.2 Localization and Feedback

Localization is the process of adapting a GRD with local information to create an SRD by local medical information groups. Local medical information teams should collaborate with global to tailor content for local use. During localization, DOF may be removed or other modifications made to comply with local laws, regulations, internal standards and procedures, and best practices. Linkage between the GRD (parent) and the local response (child) document may be established within a content management system. Local teams need to meet customers’ needs, for example, answering medical information requests and adhering to local regulations.

Local teams usually have the autonomy to tailor the GRD towards their specific requirements and HCP queries. When the GRD is extensive, the local team only uses relevant section(s) that addresses the question. This ensures that the local content aligns with the quality expectations of an SRD. However, local teams are sometimes only able to add label information based on company policy and the desire to maintain consistency in responses.

When there is no available GRD, the local team may escalate the request to global medical information or create a custom local response if it involves a local product or topic. If the request is escalated, global medical information provides content that can be used by the local team to create the SRD and fulfill the request.

While all GRDs are reviewed on a global level, local level reviews can be conducted. Newly localized responses warrant a local review in most companies even with unchanged content. Some companies forgo an additional local review if the GRD was taken as is with only local labels and disclaimers added. Local reviews may occur depending on local regulations or company policy. In some countries DOF, congress material is allowed, while in other countries, because of company policy or local best practices it is not permitted. Local reviewers are responsible for following local governance.

Different approaches exist for gathering feedback on GRDs. Some companies hold regular meetings (monthly, quarterly) with global and local medical information groups, while others rely on informal collaborations via channels such as TEAMS and e-mail. While not all companies have a specific process or channel in place, all are working on enhancing feedback and collaboration. Constructive and consistent feedback is necessary for improving GRDs with two-way communication between global and local medical information.

Regular communication between global and local teams ensures alignment of resources. Some companies have processes for local teams to provide feedback on GRD creation and format or to request new or updated GRDs. Regular meetings or communication channels facilitate the exchange of information and ensure resource alignment. Despite no universal goal, setting a target (e.g., ≥90% of requested GRD updates from local teams addressed within 3 months) could encourage and increase the impact of local feedback.

Local teams should have early visibility of planned GRD library updates, if feasible. This helps local teams understand the localization workload, adjust timing, manage resources, and ensure local resource governance.

Despite the benefits of GRDs, there are challenges in achieving global harmonization while addressing local needs. The variability in local regulations and the diverse requirements necessitate a flexible approach to GRD creation and localization.

Leveraging technology introduces an innovative approach to improving and streamlining GRD development and localization. Many companies are beginning to analyze these technologies including artificial intelligence and large language models.

3.3 Content and Format

Companies vary in the structure of content creation teams and support for GRD creation, yet some general practices in the creation and utilization of these materials exist. Below are some generally accepted approaches and best practices in GRD content creation and utilization.

3.3.1 Label Agnostic Documents

The foundational concept of a centralized GRD approach is to make core content shareable globally, excluding local labels or requirements. Some companies may provide label information in GRDs; however, these responses are updated at the local level. Typically, there will be some designation that identifies a GRD as global content that does not include specific local information (label agnostic).

3.3.2 Providing Local Specific Information

Some companies use links in the cover letter to share local label information or other local-specific content. The local team can also add links in the response to direct customers to local data or guidelines. A company’s approach to crafting and sharing responses to unsolicited inquiries depends on their inquiry management systems. If links are only in the cover letter, it is crucial to ensure they are also shared in another manner if the response document is accessed via other channels where a cover letter may not be available. Additionally, as part of any review or update to the response document, the validity of the link should be checked and updated.

3.3.3 Innovative Formats

Regarding format, while most companies continue to use Word for GRDs, some are exploring alternative formats. These formats enhance customer experience through concise summaries with interactive features, adapting to rapid technological advancements. Global response document formatting can include the use of infographics, interactive content, and modular content. These innovative content elements require a specialized skillset and additional software programs, resulting in a greater effort to create, update, and maintain. There may be additional costs and system complexities associated with the development of innovative assets. Companies must thoughtfully choose topics for innovative formats, prioritizing those that derive the greatest value, minimizing the need for frequent updates and avoiding promotional or misleading content.

Incorporating infographics into traditional “text heavy” GRDs can visually summarize complicated data and improve customer experiences. Infographics can enhance retention, increase engagement, improve patient education, allow for easy sharing with HCPs, and support decision making [7,8,9]. To prevent search problems in GRDs, create infographics directly in the document, as content in inserted images is not searchable. Furthermore, producing original infographics eliminates the high costs of licensing visuals (i.e., tables, graphs, and other assets).

Interactive content includes interactive portable document formats (PDFs, iPDFs), slide decks, or website-based content. This includes features such as buttons, links, and videos, which allow for enhanced customer engagement. Interactive content adapts to evolving customer preferences and technological development. Studies show interactive content can significantly affect comprehension and attitudes or evaluative response to medical information [10, 11].

Key considerations, in addition to the above, exist when planning on integrating interactivity into the GRD strategy. Responses with interactive content may complicate localization and translation. These documents may require links to more comprehensive responses to provide context. Moreover, to foster content creation innovation, avoid overusing colorful templates and excessively brief summaries, which may seem promotional or misleading. For digital platforms to function correctly, interactive materials must be in HyperText Markup Language (HTML).

Modular content is a content management approach that divides information into reusable modules for different uses. Modular content offers efficiency, speed, flexibility, consistency, accuracy, scalability, personalization, cost effectiveness, and collaboration benefits [12]. Tiered modular content can be created by merging interactive PDF features and modular content.

3.4 Procedures and Process

When creating a GRD, the DRESS acronym is a useful scientific method tool [13]. This process—Defining the question; Researching the data; Evaluating the evidence; Synthesizing a response; and Sharing a response—provides a roadmap for the development and systematic approach to a well written GRD.

The use of the response across the organization is an important indicator of a GRD’s value. Usage data analysis assists in refining GRD content. Resources can be reallocated to create new responses by retiring responses rarely used. Companies may struggle to accurately and effectively collect utilization metrics for global responses. With integrated content and customer fulfillment systems, companies can track the direct response use. Tracking the parent/child relationship enables full measurement of global content usage at the local level within the content management system. However, incomplete local reporting limits a full picture of GRD usage. Website usage must also be monitored to track direct customer queries. Several member companies reported creating dashboards and reports, providing easy access to GRD metrics.

3.4.1 Routine Updates

Regularly updating GRDs with current data is critical to ensure their continued value. Companies vary in both frequency and triggers for updating a GRD with many using an annual review cycle, supplemented by updates throughout the year as new key data emerge. However, this may vary throughout the life cycle of the product. Whenever a change or retirement of a document occurs, there should be a notification and a process to ensure that parent/child content is updated synchronously, preventing child responses from having outdated content. This approach preserves the integrity of the GRDs and provides HCPs with the latest data. However, the challenge lies in managing updates with available resources. Efficient solutions for maintenance of GRD libraries may include adjusted review cycles or inclusion of different grades of information based on the product’s life cycle.

3.4.2 Tracking Translations

Translations of GRDs are often required to meet specific customer needs and may be done routinely or selectively based on usage or request. While content management system metadata enable tracking translations, companies may not fully understand or monitor the extent of localization efforts.

3.4.3 Quality Review of Documents

Accuracy and completeness of GRD content are paramount, as inaccurate or incomplete information can lead to medication errors, adverse events, and regulatory non-compliance. Peer review of GRDs by medical information specialist peers and other medical colleagues ensures their quality. In addition, other departments, such as regulatory, legal, safety, and others may also review as necessary. A standardized GRD quality checklist, along with a quality-control tool, could help assess accuracy and completeness.

3.5 Metrics and Key Performance Indicators (KPIs)

Analyzing GRD metrics and KPIs are essential for ensuring effectiveness, efficiency, and impact of GRDs to satisfy internal and external customer needs [14]. Medical information departments use optimized metrics and KPIs to define augmented strategies to enhance patient outcomes. Though metrics and KPIs differ between companies, most companies evaluate GRD efficiency using usage analytics, escalation rates, and turnaround time (Table 3).

Monitoring GRD usage helps prioritize updates, ensuring that critical information is readily available to HCPs. A GRD’s usage is heavily impacted by company structures, medical information processes, and product portfolios.

Monitoring the escalation rate provides insights into the effectiveness of GRDs handling local queries. Escalation rate and response time targets should consider the product’s novelty and HCPs familiarity, ensuring adequate support during launch and early adoption phases. Regularly monitoring query topics is crucial for identifying emerging interests and potential data gaps. Regularly monitoring query topics (monthly, quarterly) helps companies identify trends and responds by creating or updating GRDs.

Robust GRD and local SRD collections are vital to ensure appropriate turnaround times for responses to the HCPs. New products may require faster responses, as HCPs have limited familiarity with them. It is important to remember that HCPs usually need the information as soon as possible to continue caring for the patient. An additional factor to consider is the speed and ease of accessing information and the channel being used. New and high-demand products benefit most from this indicator, highlighting content gaps.

Ensuring customer satisfaction is crucial for building trust and providing valuable medical information that supports better patient care, ultimately improving health outcomes. Satisfaction should be gathered as close to the interaction as possible in the most convenient channel for the customer [15].

Implementing these metrics and KPIs facilitates continuous improvement of GRDs, ultimately helping local teams, HCPs, and patients. Furthermore, inadequate reporting mechanisms in some companies or local teams can hinder precise GRD usage tracking. Continued process improvement and leveraging technology are crucial for companies to overcome these challenges. The overall goal is to ensure the highest quality of medical information disseminated in a timely manner.