Clinical trial solutions

Quick answer: BGASoft builds, integrates, and extends the systems that run modern clinical trials — CTMS, EDC, eTMF, IRT, site and subject portals, ePRO and eConsent, central-lab LIMS, safety feeds, and sponsor oversight dashboards. Twenty years of validated delivery for sponsors, CROs, and central labs, aligned to ICH E6(R3) GCP, 21 CFR Part 11, EU Annex 11, and GAMP 5 Second Edition.

The list below is the scope of work we handle inside a clinical program. Most engagements touch a subset of these; the value is in how they connect.

The clinical trial stack we work across

• CTMS — study, site, investigator, milestone, budget, and metrics management. See Central Lab CTMS and Clinical Trials CRM.
• EDC and eSource — electronic data capture, eCRF design, edit checks, query workflow, and integration with central-lab and ePRO streams.
• eTMF — Trial Master File with DIA Reference Model alignment, audit trail, and inspection-ready exports.
• IRT and RTSM — randomization, drug supply, kit management, and unblinding workflows.
• Site Portal — protocol documents, training records, payments, query response, and the day-to-day communications hub investigator sites actually log into.
• Subject Portal, ePRO, and eConsent — patient-facing onboarding, consent capture, diaries, scheduled assessments, reminders, and telehealth-friendly visit flows.
• Clinical Research LIMS and DMS — sample chain of custody and study data stewardship. See Clinical Research LIMS and Clinical Research Data Management.
• Safety and pharmacovigilance feeds — SAE intake, MedDRA coding hooks, and E2B(R3) exchange where required.
• Sponsor and CRO oversight dashboards — KRI and QTL monitoring, RBQM signal review, and study health at a glance.

How we deliver — build, buy, or integrate

Almost no trial runs on a single vendor's stack. The real question is which parts to buy, which to build, and how to keep them in sync once they are in production.

• Build when an off-the-shelf product cannot model your protocol, your therapeutic area, or your operating model — and the gap will cost more in workarounds than in code.
• Buy when a mature product covers most of your need and the remainder is configurable. We help select the system, run validated implementations, and own the integrations.
• Integrate and extend when you already own the platforms and the gap is in the glue between them — sample data not reaching EDC, payments stuck in a spreadsheet, or sponsor dashboards that lag a week behind operations.

Integration patterns we know

Clinical trial systems are only as useful as the data flowing between them. We have shipped, audited, and revalidated integrations on every common pattern in this space.

• Clinical data exchange — HL7 v2 and FHIR for EHR-to-eSource, CDISC ODM for EDC interchange, and SDTM and ADaM for submission alignment.
• Sponsor, lab, and vendor exchange — REST, SFTP, and EDI patterns for results, billing, and oversight files.
• Identity and access — SAML and OIDC single sign-on across CTMS, eTMF, site portal, and subject portal, with role mapping and audit-trail bridging.
• Safety — E2B(R3) for SAE exchange and MedDRA-aware coding hooks at the intake point.

Compliance and quality

Everything we build into a clinical program is delivered against a written validation strategy proportional to risk. The frameworks we work to:

• 21 CFR Part 11 and EU Annex 11 for electronic records and electronic signatures.
• ICH E6(R3) GCP — the risk-proportionate, system-aware revision of Good Clinical Practice now in force.
• GAMP 5 Second Edition and FDA's Computer Software Assurance (CSA) guidance for proportionate, evidence-led validation. See our Computer System Validation and Agile and 21 CFR Part 11 pages.
• HIPAA and GDPR for subject-data privacy, with data residency and consent capture aligned to the studies' regions.

Why BGASoft

• Twenty years in life sciences. The same team has shipped clinical and lab systems across sponsor, CRO, and central-lab environments since the early 2000s.
• Full-stack practitioners. Architects, developers, database experts, QA engineers, validation leads, and administrators on one team — not handoffs between contractors.
• Validated delivery. Every release is built against a written validation strategy, traced to requirements, and inspection-ready.
• Vendor-neutral. We are not reselling a single product. We pick what fits and own the integrations.

Frequently asked

Do you build custom clinical trial systems or only integrate?
Both. We build where off-the-shelf will not fit, integrate where it will, and extend systems you already own. Most engagements end up doing all three.

Which validation framework do you follow?
GAMP 5 Second Edition, risk-proportionate, with CSA-aligned testing. We map evidence to 21 CFR Part 11, EU Annex 11, and ICH E6(R3) GCP requirements depending on the study and jurisdiction.

Can you take over a trial system mid-program?
Yes. We have inherited CTMS, eTMF, and integration estates from previous vendors and stabilized them without revalidation rework where the existing controls held up.