What we offer

Four areas, one asset.

Engagements are scoped to the stage the programme is at — a single document, a full development plan, or ongoing medical monitoring.

The strategic layer: what the asset is meant to become, and the plan that gets it there.

• Integrated development plan (IDP) — coordinating every function involved in the clinical development of a drug.
• Clinical development plan (CDP) — the core strategic document for the asset. It covers the clinical aspects of development, aligns the clinical parts, and dictates the tactical and operational steps.
• Target product profile / target patient profile (TPP) — the strategic goal. It outlines the characteristics of the asset and guides the CDP toward which the clinical activities should move.
• Study and trial protocol writing — the document outlining all procedures and investigations conducted during the trial, written to fit the CDP.
• Patient reported outcomes (PRO) built into the CDP for market access.
• Health authority interaction — experience with investigational new drug (IND) applications and biologics license applications (BLA).

Case-level review through to the safety documents regulators will read.

• Individual case safety reports (ICSR), including causality and relatedness assessment.
• Safety signal detection.
• Benefit–risk assessment for the Investigator’s Brochure (IB) and the Development Safety Update Report (DSUR).
• Risk management plan (RMP) development.
• Reference safety information (RSI) and core safety data sheet development.

The external medical voice of the asset, and the evidence generated after approval.

• Key opinion leader (KOL) identification and development of a KOL engagement plan.
• KOL interaction.
• Launch and post-approval activities.
• Phase II clinical trials and registries.

Writing the data up so it survives peer review and stands up in front of a congress audience.

• Abstracts and publications in peer-reviewed journals — see a recent example on PubMed.
• Conference presentations developed to present clinical data.