Standard Response Documents
Pubrica writes standard response documents (SRDs) and builds medical information libraries for medical information and medical affairs teams. An SRD answers an unsolicited question, which makes it non-promotional and allows it to address topics that promotion cannot, including off-label questions, provided the response is balanced, referenced and reactive. Our medical information writers prepare each SRD and build an indexed, versioned library that keeps responses consistent.
- Reactive by definition, because an SRD answers an unsolicited enquiry, which keeps it outside promotional rules
- Balanced and fully referenced, including data that does not support the product, because a one-sided response is promotional material
- Written at two levels, with a direct answer for the enquirer and supporting detail for readers who need it
- Built as a library, versioned and indexed, so the same question receives the same answer throughout the year
- Maintained against the label and the literature, since an SRD citing a superseded analysis is worse than no SRD
SRDs written and referencedIncluded
Library built, indexed and versionedIncluded
Balanced treatment including negativesIncluded
Maintenance against label and literatureIncluded
Proactive distribution of an SRDNot offered, as this would be promotional
Enquiry → matched → answered → referenced → recorded
- Reactive use only
- Balanced, including unfavourable data
- Every statement referenced
- Versioned in an indexed library
- Maintained against the current label
Deliverables
Four Components of Every Standard Response Document Library
A library provides consistency, so the same question receives the same answer whoever handles it.
Example from an SRDThree studies support use in this population.Three studies report benefit in this population; two of the three were post hoc analyses and were not powered for it. One further study found no significant difference. All five are summarised below with their designs and limitations.
Example structureEnquirers are usually clinicians with a patient waiting. An answer buried under the evidence is difficult to use and can appear evasive.
Example from a library structureThe common failure is a shared folder of documents with no index and no review dates, where the newest version and the most findable version are different files.
Example from a review cycleEnquiry volume is itself data. Three enquiries a month on a topic with no SRD indicate a gap in the library, and often a gap in the evidence.
The samples shown are illustrative and anonymised. Hover over a sample to replay it.
Compliance and Standards
Medical Information Standards: PhRMA Code, GPP 2022 and ICMJE
Reactive scientific communication has its own rules, and they are narrower than they appear.
PhRMA Code (and the OIG speaker program alert)
The Code revisions effective January 2022 responded directly to the OIG Special Fraud Alert of November 2020. The alert’s suspect characteristics, including minimal educational content, alcohol, unsuitable venues, repeat attendance, sales-influenced speaker selection and compensation above fair market value, define the boundary.
GPP 2022 (good publication practice)
The 2022 update replaces GPP3. It covers company-sponsored research, including translational, biomarker and real-world studies, and extends to preprints, plain language summaries and social media. Professional medical writing support is legitimate, provided it is disclosed.
ICMJE Recommendations (authorship and disclosure)
Sets four criteria, all of which each author must meet. Contributors who do not meet all four are acknowledged. Employment by the sponsor neither qualifies nor disqualifies anyone.
Quality management (cert. H3CR9TCU20251212INDQM10N)
Our certified quality system governs how work is run, recorded and released.
Responsible Use of AI
Our Approach to AI Use in Medical Information
Medical affairs work must distinguish scientific exchange from promotion, a boundary that regulators monitor. That judgement depends on context, jurisdiction and the individuals involved, so it is always made by our specialists rather than by an AI tool.
Why We Do Not Publish AI Accuracy Figures
Accuracy figures for AI tools are usually reported by the companies that sell them.
Pubrica therefore does not quote a self-generated accuracy figure, because it would carry the same conflict of interest. Instead, we tell you which tool was used on your project, at which stage, and what a specialist changed afterwards.
Our Process
How Our Standard Response Document Process Works
We start from the enquiries you already receive, which are the most reliable guide to what the library needs.
Enquiry analysis
We review existing enquiries to identify the questions being asked and those the current library does not answer.
Evidence and drafting
We write each SRD from the evidence, balanced and referenced, with a direct answer first and the detail behind it.
Library structure
We index documents by question and assign versions, review dates and owners, so handlers can find and rely on the right document.
Maintenance
We review documents on a schedule against the label and the literature, and use enquiry patterns to identify new documents.
Our Experts
Your Medical Information Team
A named team of subject specialists stays with your project from scoping to delivery. Your project coordinator introduces each team member by name before work begins.
Reviews the scientific content for accuracy and confirms that each conclusion is supported by the evidence. Each expert is matched to your field.
Writes the content against the brief and the applicable code of practice, with every claim traceable to its reference.
Reviews the content for scientific accuracy, fair balance and compliance with the applicable code before it reaches your internal review.
Manages the timeline, keeps you informed at each stage and coordinates the team so that questions are answered and deadlines are met.
Packages
Medical Information Packages
Costs depend on the number of documents and the amount of evidence each must synthesise.
Document set
For a defined set of questions
Quoted per projectBased on document count
Delivery Agreed at scoping
- ✓Enquiry analysis to set scope
- ✓Each SRD balanced and referenced
- ✓Direct answer plus supporting detail
- ✓Limitations and unfavourable data included
- ✓Consistent format across the set
- ✓Review dates assigned
Scope is set from your actual enquiries rather than from a standard topic list.
Deliverables Request a quoteLibrary build
For a full medical information library
Quoted per projectBased on indication and document count
Delivery Agreed at scoping
- ✓Complete document set
- ✓Index by question and topic
- ✓Version control and ownership
- ✓Review schedule per document
- ✓Handler guidance on matching enquiries
- ✓Escalation route for unanswered questions
The index is what turns a set of documents into a library.
Deliverables Request a quoteMaintenance
For libraries in use
Quoted per projectBased on library size and update frequency
Delivery Scheduled
- ✓Review against label changes
- ✓New literature folded in
- ✓Superseded content withdrawn
- ✓Enquiry patterns analysed for gaps
- ✓New documents written for recurring questions
- ✓Version history maintained
A recurring enquiry with no SRD is the clearest sign of a gap in the library.
Deliverables Request a quoteSend an anonymised enquiry log for one quarter, and we will identify the questions your library does not currently answer at no cost.
FAQs
Frequently Asked Questions About Medical Information and SRDs
If your question is not answered here, please ask an expert. No quote is required.
A reactive response to an unsolicited question may address off-label topics, provided it is truthful, balanced, non-promotional and referenced, and comes from medical information rather than a commercial function.
Distributing that content proactively turns it into promotion of an unapproved use. The framework depends on the enquiry being unsolicited.
Yes. Balance is what makes the document non-promotional. A response presenting only supportive evidence is promotional material in a different format.
Balance also makes the response credible to the clinician who asked, who will often already know about the negative study.
Field teams should provide an SRD only in response to an unsolicited question on that topic and in line with your own SOP. Carrying SRDs to distribute is proactive use.
Most organisations route enquiries to medical information rather than answering them during the visit, because the boundary is easier to maintain that way.
Each document should be reviewed on a defined schedule, and immediately after a label change or a pivotal publication.
An SRD citing a superseded analysis is worse than having no SRD, because it is sent out under the company’s name.
Related Services
Related Medical Affairs Services
Enquiries arrive through the field team, the website and the call centre, and each needs the same answer.
Request a Free Gap Analysis of Your Medical Information Enquiries
Recurring questions with no standard response show where the library needs new documents, and they often indicate evidence gaps.