BRIGHTX

Capabilities

Every clinical development function, in-house. No hand-offs to sub-contractors you haven't met.

BRIGHTX is a full-service CRO — regulatory, clinical operations, biometrics, pharmacovigilance, and clinical supply all sit under one roof. Our operational playbooks come from Bright Pharmaceutical Services, which has been running these functions for pharma, biotech, device, and government clients since 2002. We don't build study teams from scratch for each program. We assign from a vetted bench of known staff we've worked with and consider to be the best our industry has to offer — people with a patient-first mentality and a track record that speaks for itself.

Clinical operations

1,000+ active investigators across our statewide Texas site network.

Global Clinical Development

We manage Phase I–IV trials across 50+ countries with a risk-based monitoring approach — central data review, triggered on-site visits, and real-time CTMS visibility for sponsors. Our CRAs are direct employees, not contractors, and site selection is driven by our own feasibility database built from 20+ years of Bright Pharmaceutical Services site relationships. Hybrid and decentralized models are fully supported, including home health and e-consent workflows.

Phase I–IVRisk-Based MonitoringSite Selection & FeasibilityDecentralized / DCT

Regulatory & Quality

IND, CTA, and IDE preparation for FDA, EMA, Health Canada, PMDA, and NMPA. Our regulatory team has prepared Type A, B, and C meeting packages and represented sponsors in formal agency interactions. eCTD publishing is handled in-house. Our QMS is built on ICH-GCP, ICH E6(R2), and ICH Q10 frameworks, and our teams are prepared for FDA, EMA, and MHRA inspections from day one.

IND / CTA / IDEFDA / EMA / PMDAAgency MeetingseCTDICH-GCP

Biometrics & Data Sciences

Statistical analysis plan development, CDISC-compliant SDTM and ADaM datasets, and submission-ready statistical packages. We select EDC, ePRO, and data management platforms based on your program, budget, and size — not our preferred vendor relationship. Medical coding uses MedDRA and WHO Drug. Electronic submission-ready datasets are standard, not an upgrade.

SDTM / ADaMSAP DevelopmentMedDRA / WHO DrugePROVendor-Agnostic

Safety & Pharmacovigilance

Individual case processing (CIOMS-I, MedWatch, SUSAR), aggregate reporting (DSUR, IND annual report, PBRER), and ongoing signal detection. We manage safety databases in both Argus and ArisG depending on sponsor preference. Our safety team operates 24/7 for case intake and is staffed by medical monitors with clinical and regulatory backgrounds.

CIOMS-I / MedWatchDSUR / IND Annual ReportArgus / ArisGSignal Detection

Clinical Supply & Logistics

IRT/RTSM integration, comparator sourcing, labeling and packaging for international shipments, and cold-chain management including direct-to-patient depots. We select IRT/RTSM vendors based on your program's complexity and budget — the right tool for the job, not the most expensive one. Our Texas-based supply operations simplify import/export for CPRIT-funded programs requiring U.S.-based chain of custody documentation.

IRT / RTSMComparator SourcingCold ChainDirect-to-Patient

How we work with sponsors

From protocol to final report.

BRIGHTX runs studies SOP-to-SOP. Our inspection-ready quality systems, vendor-agnostic technology approach, and transparent reporting cadence are table stakes — not upgrades. For CPRIT programs, we document Texas-spend allocation throughout the study so compliance reporting is ready when your program officer asks for it.

01 / Scoping

Protocol review, feasibility assessment, and budget development within two weeks. For CPRIT programs, we map spend allocation from the first budget draft.

02 / Team Assembly

Named project manager, clinical lead, medical monitor, and data management lead assigned before contract execution. You meet the actual team, not a pitch team.

03 / Execution

Site activation, enrollment tracking, and data review in a shared CTMS dashboard. Weekly status calls, monthly metrics reports, and real-time issue escalation — no surprises.

Technology stack

We don't select systems because they're our preferred vendor. We select the EDC, CTMS, eTMF, safety database, and IRT that are the best fit for your program, your budget, and your team's workflows — then integrate them so data flows without manual bridging.

Partnership model

Full FSO, FSP, and functional service agreements available. Already aligned with major Texas academic medical centers and site networks — scale-up doesn't require new contracts or new introductions.