Clinical Development · CRO
Evidence That
Stands Up. Day One.
Phase I–IV trial operations, clinical data management, biostatistics & SAS programming and patient recruitment — designed from kick-off to satisfy regulators and payers. No retro-fitting at submission.
Phase I–IVFull-Service Ops
Overview
Trials Designed for Regulators AND Payers
Traditional CROs run trials. Vigilare runs programmes. Every protocol is built with the regulatory dossier and the HTA value story in mind — not as separate downstream activities, but as design constraints baked into the SAP from day one.
Biostatistics, data management, medical monitoring, site activation and patient recruitment all run under the same ISO 9001:2015 quality system as our PV, regulatory and market access teams — one accountable programme, not five vendors.
- Phase I through Phase IV trial operations under one accountable team
- In-house biostatistics and SAS programming — no outsourced black box
- CDISC SDTM/ADaM standards from day one
- Protocols co-designed with regulatory and market-access leads
Offerings
Every Clinical Function. One Programme View.
Six integrated clinical capabilities, delivered by named senior leads — engage as workstreams or as full-service CRO partnership.
Phase I–IV Trial Operations
End-to-end clinical operations: protocol design, IRB/EC submissions, site selection, monitoring, vendor management and trial-master-file oversight.
Clinical Data Management
EDC build (Medidata Rave, Veeva CDMS, Oracle Clinical One), data validation, query management, CDISC SDTM mapping and database lock.
Biostatistics & SAS Programming
SAP authoring, sample-size calculations, adaptive design, interim analyses, ADaM datasets, TLF programming, define.xml — fully in-house.
Medical Monitoring & Safety
24/7 medical monitor cover, eligibility review, SAE/SUSAR oversight, DSMB liaison and protocol-deviation adjudication.
Patient Recruitment & Sites
Site feasibility, activation, patient-facing recruitment campaigns, digital screening, retention programmes and patient-engagement metrics.
Decentralized & Adaptive Trials
ePRO/eCOA, telemedicine visits, home-nursing, wearables integration, adaptive Bayesian designs, basket and platform trials.
I–IVPhase Coverage
30+Countries · 5 Continents
24/7Medical Monitor Cover
10+Years Clinical Mastery
Our Process
From Protocol to Locked Database
A five-stage clinical operations framework that protects data integrity and protocol fidelity at every step.
01
Protocol
Design, SAP, eligibility, schedule of assessments — co-designed with reg + MA.
02
Activate
Feasibility, site selection, IRB/EC, contracting, EDC build, vendor setup.
03
Conduct
Enrollment, monitoring, data capture, queries, medical review, safety oversight.
04
Lock
Final query resolution, SDV close-out, database lock, blind data review.
05
Report
Statistical analysis, TLFs, CSR authoring, CDISC packages, submission datasets.
Why Vigilare
Built for the Submission, Not Just the Trial.
Four reasons emerging biopharma choose Vigilare over traditional global CROs.
Biostatistics & SAS In-House
SAP design, programming and review handled by senior biostatisticians on our team — no offshore programming black box, no version drift.
Programme, Not Project Mindset
Protocols are designed with the dossier and HTA value story in mind from day one — your data answers regulators and payers.
CDISC SDTM/ADaM From Day One
Standards-aligned data capture from the EDC build outward — no end-of-study CDISC reformat scramble at database lock.
Global, Without Enterprise Overhead
Site networks across 30+ countries with the responsiveness of a focused mid-size CRO — no offshore handoff lag.
FAQs
Clinical Development, Answered.
01
Can you take over a trial mid-flight from another CRO?
Yes. Rescue studies are a common engagement model. We start with a 14-day diagnostic — TMF state, site relationships, query backlog, EDC config — agree a recovery plan, and step in as CRO of record with full data and operational continuity.
02
Which EDC platforms do you support?
Most commonly Medidata Rave, Veeva CDMS, Oracle Clinical One and Castor EDC. We support sponsor-provided systems, migrations between platforms, and full EDC + IRT integration.
03
Do you handle decentralized and hybrid trials?
Yes — full DCT and hybrid-trial design including ePRO/eCOA, televisits, home-nursing networks, wearable device integration, direct-to-patient drug shipping, and remote monitoring. We've delivered both fully-virtual and site-augmented hybrid designs.
04
What's your geographic reach for site activation?
Active site networks across North America, EU, UK, India, Australia, ASEAN and the Middle East — 30+ countries total. We maintain country regulatory affairs partnerships for fast IRB/EC submissions in each.
05
Can you support orphan and rare-disease trials?
Yes — small-N adaptive designs, basket trials, master protocols, single-arm with synthetic controls, and patient-finding through advocacy partnerships. We have direct experience in rare oncology, neurology and metabolic indications.
Related Services
Pair CRO with the Full Lifecycle
Bundle clinical with safety, regulatory, market access and quality — one team, one quality system.
Need a CRO that thinks like your dossier?
Speak to a senior clinical lead — not a sales rep. We'll scope your protocol, map the design risks and propose a path in one focused call.