Investigator’s Brochure Writing for Drug and Biologic Sponsors
Pubrica writes investigator’s brochures for drug and biologic sponsors, from first-in-human brochures to annual updates. Our regulatory medical writers prepare the brochure from the source data package so that it presents the full nonclinical and clinical picture in a form investigators can use. We also keep it current, because a brochure that has not absorbed the last twelve months of safety data is a GCP compliance issue.
- Written from the data package — nonclinical pharmacology and toxicology, clinical pharmacology, efficacy and safety — rather than assembled from previous versions
- A clearly defined reference safety information section, because expectedness assessment for SUSAR reporting is judged against it
- Practical guidance for the investigator covering dosing, monitoring, management of known risks and the action to take when an adverse event occurs
- Annual updates on schedule under ICH E6(R3), with the new safety data integrated rather than appended
- Consistent with the protocol and the ICF, because an inspector checks first whether the three documents describe the same risk consistently
Full investigator’s brochureIncluded
Reference safety information sectionIncluded
Annual updateIncluded
Consistency check against protocol and ICFIncluded
Expectedness assessment of individual casesYour safety function
Data package → assessed → written → reconciled → brochure
- Written from the source data package
- Reference safety information defined precisely
- Reconciled with protocol and ICF
- Update cadence set at the start
- Usable by a clinician at the bedside
Deliverables
Four Core Elements of Every Investigator’s Brochure
Each brochure covers one investigational product, and its content is determined by what the nonclinical and clinical data show.
Example from an investigator guidance sectionInvestigators should monitor patients appropriately.Liver function tests at screening, day 14 and monthly thereafter; hold study drug if ALT exceeds three times the upper limit of normal; discuss with the medical monitor before rechallenge. Actionable at the bedside.
Example from an RSI sectionThe RSI is a defined, dated list of expected serious adverse reactions with frequencies, kept separate from the general safety discussion. A vague RSI turns every SUSAR assessment into a judgement call under time pressure.
Example from a nonclinical summaryFindings in the 13-week rat study included hepatocellular hypertrophy.Hepatocellular hypertrophy at exposures four times the proposed human dose, reversible on recovery, and the basis for the liver monitoring schedule in section 7. The finding and its clinical consequence, together.
Example from a consistency checkRisk language is compared line by line across the IB, protocol and ICF. Each difference is either resolved or documented as deliberate, because an inspector will identify it.
The samples shown are illustrative and anonymised. Hover over a sample to replay it.
Compliance and Standards
Four Governing Standards and Guidelines for Investigator’s Brochures
Where your sponsor template or the relevant agency states a position, that position takes precedence.
Good Clinical Practice (E6(R3), not E6(R2))
Principles and Annex 1 took effect in the EU in July 2025; Annex 2, covering pragmatic and decentralised designs, follows in January 2027.
Clinical safety data management (expectedness definitions)
The definitions of serious, unexpected and suspected that the reference safety information section has to support.
Structured protocol (Step 4, November 2025)
The protocol the brochure sits alongside. Where a trial is written to M11, the risk and monitoring language should map cleanly between the two.
Quality management (cert. H3CR9TCU20251212INDQM10N)
How the document is drafted, reviewed, version-controlled and released.
Responsible Use of AI
Responsible Use of AI in Regulatory Writing
Regulatory reviewers trace each decision back to its evidence and to a responsible individual. For this reason, we treat source traceability as more important than drafting speed, and every statement in a regulatory document must be traceable to its source.
Why We Do Not Publish an AI Accuracy Figure
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.
Methodology
How We Write Your Investigator’s Brochure
We assess the data package before writing, because a brochure assembled from its previous version inherits that version’s gaps.
Data package review
We review the nonclinical study reports, clinical pharmacology, any completed clinical studies and the current safety database to identify what a clinical reader needs.
Structure and RSI scope
We agree the brochure structure and settle the scope of the reference safety information explicitly, because it governs expectedness assessment for the whole programme.
Drafting
We write for the investigator, translating nonclinical findings into their clinical consequences and providing guidance that can be followed in practice.
Reconciliation and release
We check the brochure against the protocol and the consent form for consistent risk language, then release it with the next update date set.
Our Experts
Our Regulatory Writing Team
A named team of regulatory specialists stays with your project from scoping to delivery. Your project coordinator introduces each team member by name before work begins.
Writes the document against the governing template and regulatory guidance, keeps every statement traceable to its source data, and maintains the version history and comment log through each review round.
Reviews the clinical and scientific content for accuracy and confirms that each conclusion is supported by the data. Each expert is matched to your therapeutic or device area.
Checks that statistical methods, tables and conclusions are consistent with the analysis plan, and reviews how the data are presented before the document reaches regulatory review.
Performs an independent check of the final document against source data, the template and the applicable regulatory checklist. Findings are logged and resolved before delivery.
Packages
Investigator’s Brochure Writing Packages
Pricing depends on the size of the data package, the development stage and whether an existing brochure is available to work from.
Investigator's brochure
For first-in-human brochures or brochures being rebuilt
Quoted per projectOn data package size and development stage
Delivery By scope
- ✓Full brochure written from the source data package
- ✓Reference safety information section defined precisely
- ✓Practical guidance for investigators
- ✓Reconciled against protocol and consent form
- ✓Two review cycles
Where no brochure exists yet, the scope of the reference safety information is the decision that deserves the most attention.
Deliverables Request a quoteAnnual update
For sponsors with a brochure due for its annual revision
Quoted per projectOn new data volume
Delivery By scope
- ✓New nonclinical and clinical data integrated, not appended
- ✓Reference safety information reassessed against the current database
- ✓Guidance revised where the safety picture has moved
- ✓Consistency re-checked against the current protocol
- ✓Change summary for the ethics committee
We recommend a standing arrangement for annual updates, because brochures become overdue when no one is responsible for the date.
Deliverables Request a quoteSend us the current brochure and the last twelve months of safety data, and we will tell you free of charge whether the reference safety information still supports your expectedness assessments.
FAQs
Investigator’s Brochure FAQs
If your question is not answered here, ask an expert — no quote is required.
At least annually under ICH E6(R3), and sooner where new information is significant enough to change how an investigator would run the trial or manage a participant.
In practice, the trigger is usually a safety signal or a completed study. The update cadence should be documented, because an overdue brochure is an avoidable inspection finding.
It is the defined list of expected serious adverse reactions against which individual cases are assessed for expectedness — which determines whether a case is a SUSAR requiring expedited reporting.
If the RSI is written loosely, every assessment becomes a judgement call made under a seven- or fifteen-day reporting clock. If it is written precisely, most cases can be assessed straightforwardly. It is one of the most important sections of the document.
Yes — a first-in-human brochure is written from the nonclinical package and clinical pharmacology, and that is the common starting point.
The structure set at that stage is inherited by every later version, so it should be established correctly at the outset rather than restructured later.
It has to be consistent with it. The IB is the fuller document; the protocol carries the operational detail. Where they describe the same risk differently, that difference is a finding.
We reconcile the three documents an ethics committee reads together — brochure, protocol and consent form — and report where they diverge.
No. Case intake, coding and expectedness assessment sit with your pharmacovigilance function. We write the document those assessments are made against.
This separation is deliberate, because a writer who also made the expectedness decisions would be reviewing their own work.
Related Services
Related Regulatory Writing Services
The IB is one of three documents that investigators and ethics committees read together.
1RELATED TRIAL DOCUMENTSmust be consistent with the IB
Clinical trial supportProtocol, ICF, SAP and disclosure. Regulatory writingSubmissions, DSURs and RMPs.2CLINICAL STUDY REPORTINGafter the study completes
Clinical study reportFull, abbreviated or synoptic, to ICH E3. Patient narrativesDeaths, SAEs and discontinuations.3SUPPORTING EVIDENCEnonclinical and clinical
BiostatisticsAnalysis from the locked dataset. Literature review and gap analysisWhat is already established.Request a Free Review of Your Reference Safety Information
We will tell you free of charge whether the reference safety information still supports your expectedness assessments. RSI that no longer reflects current data can affect expectedness assessments and safety reporting.