Hire an LLM Engineer, Boston
Boston-area biotech and pharma companies, Moderna in Cambridge, Vertex Pharmaceuticals on Fan Pier, Biogen in Cambridge, the Broad Institute, face a specific LLM engineering problem: the standard approach of prompting a general-purpose model and accepting its output does not work when the output feeds a regulatory submission or a clinical database.
The two requirements that shape every Boston biomedical LLM pipeline: every extracted value must be traceable to its source location in the document, and hallucinations must be detectable and caught before they reach the data store. We build the citation layer and the reconciliation checks that make this possible.
Pricing is scoped to the pipeline: regulatory-grade builds with full validation packages cost more than a straightforward extraction pipeline.
Describe the clinical or regulatory document you need to extract from.
General-purpose models were not trained on the specific terminology used in ICH E6 guidelines, FDA drug approval documents, or the statistical methods sections of Phase III trial reports. Terms like "per-protocol population", "estimand", and "multiplicity-adjusted p-value" have precise meanings that a general model may paraphrase incorrectly. The extraction pipeline needs either a domain-adapted model or explicit terminology instruction in the system prompt.
Long documents are the norm in clinical settings. A clinical study report can run 500 to 1,000 pages. Passing the full document to an LLM is not viable on context window size or cost grounds. We design section-level chunking strategies that split the document along its defined structure (ICH sections, table identifiers, appendix markers) and route each chunk to the appropriate extraction prompt.
Hallucination in a clinical extraction is not a UX problem, it is a regulatory risk. An extracted adverse event incidence rate that differs from the source document by 0.1% is a data integrity issue. Every extraction in our biomedical pipelines includes a source citation. A post-extraction reconciliation step retrieves the cited location from the source document and verifies that the text there supports the extracted value.
For pipelines that touch GxP data at Moderna or Biogen, we document the validation requirements for 21 CFR Part 11 compliance: electronic audit trails, model and prompt version locking, and a validation package (IQ/OQ/PQ) showing that the system behaves as specified. This is part of the deliverable, not an afterthought.
General models substitute near-synonyms for defined regulatory terms. Fix: system prompt glossary for your specific therapeutic area and regulatory framework.
Adverse event tables reference definitions from earlier sections. Chunked extraction loses this context. Fix: include section-level context headers in each chunk.
Multi-field records where fields come from different document sections are assembled incorrectly. Fix: hierarchical schema design with per-section extraction and a separate assembly step.
The model invents a plausible-sounding value when the source is ambiguous. Fix: mandatory source citation on every extraction, with reconciliation check against the cited location.
The evaluation set for a Boston biomedical pipeline is built from historical documents with known-correct field values, verified by your scientific staff. We measure field-level precision and recall separately for each document section type: narrative, table, appendix. Precision and recall requirements are agreed before build starts.
For clinical study reports destined for FDA submission, a field precision of 99%+ is often required for primary endpoint data. For internal research databases at the Broad Institute, 95% may be acceptable with a clear human review step for flagged records. We calibrate the confidence threshold to hit the precision target you specify.
Post-launch monitoring runs a weekly sample of 50 documents through the pipeline, compares against manual extraction by a qualified reviewer, and reports accuracy per field type. If accuracy drifts below threshold, it surfaces as an alert before it affects a submission.
Share a sample document and describe the fields you need to extract. We will review it and reply with a technical approach and price range within one business day.