INVESTIGATOR BROCHURE SUPPORT SERVICES
BioBoston CRO provides Investigator Brochure writing services for sponsors that need a structured, source supported document describing the investigational product, relevant nonclinical and clinical evidence, known and potential risks, and information investigators need to conduct the study. Support can cover initial authoring, scheduled updates, substantial revision, rescue of an existing draft, or independent review.
Global Reach
Therapeutic Area Coverage
Years of Experience
START A CONVERSATION
Select the support you need and share a few details about your project. We’ll use this information to route your inquiry to the appropriate BioBoston team member.
Please do not submit confidential, patient-identifiable, or proprietary information through this form.
The engagement should be scoped around the current state of the work, the intended decision or milestone, the source package, and the sponsor's approval responsibilities.
Create a structured document from approved product, nonclinical, clinical, pharmacology, safety, manufacturing, and regulatory sources
Assess new evidence, safety information, product changes, study experience, prior commitments, and sections affected by the update.
Reconcile terminology, product descriptions, evidence, risks, version history, unresolved comments, and protocol interfaces before finalization.
when needed
Problems
The service is most valuable when the team can identify the specific control gap, decision, deliverable, or
recovery need rather than requesting generic capacity.
Scope
The exact scope depends on the maturity of the work, the quality of the inputs, the sponsor’s procedures,
the review model, and the target milestone.
Deliverables
Deliverables should be confirmed at kickoff and linked to defined sponsor decisions, review cycles, and downstream handoffs.
Client inputs
The sponsor does not need every detail finalized before kickoff, but approved decisions, open questions, source owners, reviewers, and deadlines must be distinguishable.
Process
1. Confirm the intended use, supported studies, current version, update trigger, source package, reviewers, milestone, and authoring role.
2. Assess the current document and sources; create the impact map, source matrix, authoring plan, and open item tracker.
3. Draft or revise the affected sections while maintaining consistency across product, evidence, risk, and investigator guidance.
4. Coordinate cross-functional review and route unresolved medical, safety, regulatory, nonclinical, clinical, and CMC decisions to designated owners.
5. Resolve comments, perform source and consistency quality checks, and prepare the change summary and clean/redline package.
6. Support sponsor approval, distribution, document-control handoff, and future update planning as defined in scope.
Considerations
The work should remain proportionate to the risk and intended use, follow the sponsor’s controlled process, and preserve clear sponsor decision authority.
Engagement options
BioBoston leads the defined scope from assessment and planning through drafting or execution, review, quality control, and handoff.
BioBoston addresses a specific section, decision, backlog, finding, vendor issue, or stalled deliverable without expanding the engagement unnecessarily.
BioBoston provides an objective second-line review, oversight role, or embedded specialist while the sponsor or another vendor retains primary execution.
RELATED SERVICES
Align product, dosing, route, risk, monitoring, terminology, and study context between the Investigator Brochure and the complete protocol.
Coordinate approved integrated evidence and safety interpretations that may inform broader regulatory summaries and brochure updates.
Maintain consistency between the Investigator Brochure and related application documents and Common Technical Document content.
Address regulatory strategy, update expectations, authority context, and submission or notification requirements related to the brochure.
Expertise
Investigator Brochure experience should match the product, development stage, evidence package, safety complexity, update trigger, regions, and studies the document will support.
RESOURCES
Explore the following resources for additional insights and information relevant to this service.
A planned checklist for new evidence, safety information, product changes, protocols, sections affected, sources, decisions, and version control.
A planned tool connecting sections to product, CMC, nonclinical, clinical, pharmacology, safety, and regulatory sources.
A planned review framework for consistency, evidence, risk, investigator guidance, terminology, references, change history, and approvals.
FAQs
Yes. Initial authoring can begin with an approved outline and source package covering the product,
nonclinical and clinical evidence, pharmacology, safety, risks, and information required for investigators. The sponsor’s medical, safety, regulatory, and product owners approve the content.
Yes. An update should begin with an impact assessment of new evidence, safety information, product
changes, protocols, regulatory decisions, current sources, version history, and sections affected.
Yes. A focused review can assess source traceability, consistency, completeness, medical and safety content, cross-document alignment, references, version history, change control, or distribution readiness.
The Investigator Brochure summarizes relevant product and development information for investigators.
The protocol defines the specific study design, procedures, population, assessments, and operational
requirements. The two documents should align but serve different purposes.
Useful inputs include the current brochure, update trigger, data cutoff, new source documents, protocols supported, safety and medical decisions, product changes, prior regulatory feedback, review owners, and target approval date.
Any reference-safety-information decision must be owned and approved by the sponsor’s qualified
medical, safety, and regulatory functions. BioBoston can support authoring, source integration, review coordination, and document consistency within that approved framework.
PROJECT FORM
Share whether the need is initial authoring or an update, the product and development stage, current document status, update trigger, source readiness, supported studies, and target milestone. A BioBoston team member will review the request and follow up regarding fit and possible next steps.
Please do not submit confidential, patient-identifiable, or proprietary information through this form.
A productive first discussion identifies the product, studies supported, current brochure, update trigger, new evidence, safety and regulatory owners, reviewers, and next milestone. BioBoston can then define the authoring, impact-assessment, review, and quality-control scope.
