The Problem
Protocol authoring takes 12–16 weeks per trial and remains a top reason for first-cycle FDA refusals. Most delays come from inconsistencies between inclusion criteria, endpoints, and statistical sections.
We'd love to meet you in person. Drop by our office in Pondicherry, or reach out online.
Address
No 48/1, Plot no 73, 1st Floor, Aziz Nagar, 2nd Cross Street, Reddiarpalayam, Oulgaret Municipality, Pondicherry – 605010
Phone
+91 88387 24261Agent that drafts ICH E6(R3)-compliant trial protocols from a sponsor brief, prior precedent, and current FDA/EMA guidance.
Protocol authoring takes 12–16 weeks per trial and remains a top reason for first-cycle FDA refusals. Most delays come from inconsistencies between inclusion criteria, endpoints, and statistical sections.
A specialised agent that retrieves indication-specific precedent, applies your sponsor template, and runs internal consistency checks across schedule of activities, eligibility, and endpoints — flagging deviations from current regulatory guidance.
A domain-tuned agent that ingests filings, transcripts, and market data to produce analyst-grade investment memos with citations.
Agent that handles tail-spend supplier negotiations end-to-end: RFQ, counter-offer, and contract redlining within sourcing policy.
Agent that triages alerts, correlates signals, and drives incident response runbooks — escalating to humans only when judgment is required.