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Trial Governance & Oversight — Glossary

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The committees, roles, and bodies that govern a clinical trial — who oversees what, who decides what, and where the operational coordination overhead lives.

Terms covered:

Joint Steering Committee (JSC)

Definition. The senior governance body in a multi-party clinical program — typically a co-development partnership between a biotech and pharma, or between two pharma companies. Made up of senior representatives from each party (typically 3-5 per side, including clinical, regulatory, commercial, and finance leadership). The JSC sets strategic direction, approves major decisions, and resolves escalated issues.

In practice. A typical JSC:

  • Meets quarterly (sometimes monthly during high-intensity periods)
  • Reviews trial progress, safety signals, regulatory interactions, budget vs. actuals
  • Approves protocol amendments, expansion into new indications, decisions to advance / halt programs
  • Resolves disputes that the operational committees can't resolve themselves
  • Receives a "JSC pack" — a consolidated briefing document — typically 1-2 weeks before each meeting

For Adagene's collaborations with Merck, Sanofi, Roche, and Incyte, there is likely a separate JSC for each major partnership.

Why it matters. The JSC pack is one of the highest-friction recurring deliverables in a multi-partner biotech. Aggregating data across operational systems, partner contributions, regulatory updates, and financial actuals into a coherent narrative typically consumes 1-2 weeks of CRA / project manager / finance / regulatory time per meeting per JSC. Multiply by the number of JSCs across a partner-heavy biotech, and this is a real annual cost.

Where Flusso fits. Pre-built JSC dashboards refreshed continuously from source systems mean the pack is always near-current. Final assembly drops from 1-2 weeks to 1-2 days. The JSC discussion can shift from "verify the data is right" to "decide what to do about it" — which is the conversation the JSC is actually for.

Related: Joint Operations Committee (JOC) · Co-development agreement

Joint Operations Committee (JOC)

Definition. The operational counterpart to the JSC — typically composed of mid-level operational leads from each party (clinical operations, project management, data management, regulatory operations). Where the JSC sets direction, the JOC executes.

In practice. A typical JOC:

  • Meets weekly or biweekly
  • Coordinates day-to-day trial execution across parties
  • Reviews enrolment progress, site activation, query rates, monitoring findings
  • Manages the operational "true-up" of partner contributions (cost-share reconciliation)
  • Escalates issues to the JSC when needed

Why it matters. The JOC is where the multi-party coordination actually happens, and where the cross-system reconciliation pain is felt most acutely day-to-day. Each JOC meeting needs current operational data from every contributing party's systems.

Where Flusso fits. A continuous, shared operational view across parties means the JOC stops spending its time aligning on "what the numbers actually are" and starts spending its time managing what the numbers say.

Related: JSC · Co-development agreement

Safety Review Committee (SRC)

Definition. A committee responsible for ongoing review of safety data within a clinical trial or program. Reviews adverse events (AEs), serious adverse events (SAEs), suspected unexpected serious adverse reactions (SUSARs), and emerging safety signals. Distinct from a DSMB / IDMC, which is independent and unblinded; the SRC typically operates within the sponsor (or sponsor-partner) organisation.

In practice. A typical SRC:

  • Meets at defined intervals (monthly, quarterly) and ad hoc when safety signals emerge
  • Reviews AE/SAE/SUSAR data from the EDC and the safety database
  • Reviews protocol-deviation patterns, dose-modifications, discontinuations
  • Recommends protocol amendments, dose adjustments, or trial-pause / trial-stop actions
  • Receives an "SRC pack" — typically including AE listings, frequency tables, narrative summaries for SAEs, and signal-detection outputs

Why it matters. Like the JSC, the SRC pack is a recurring high-friction deliverable. Cross-trial safety signal aggregation (looking for patterns across multiple trials of the same asset) is particularly difficult when each trial's safety data lives in a separate EDC instance.

Where Flusso fits. Cross-trial safety signal aggregation is exactly the kind of cross-source-system view that's hard to build but easy to maintain once built. SRC packs become continuously-refreshed rather than retrospectively-assembled.

Related: DSMB / IDMC · Pharmacovigilance

Data Safety Monitoring Board (DSMB) / IDMC

Definition. An independent committee of external experts (typically clinicians, biostatisticians, and ethicists) who review unblinded interim safety and efficacy data during a clinical trial. The DSMB (also called Independent Data Monitoring Committee, IDMC) makes recommendations about whether to continue, modify, or stop the trial. They are independent of the sponsor — that's the entire point.

In practice. A typical DSMB / IDMC:

  • Reviews unblinded data at protocol-defined interim analyses
  • Receives data through an unblinded statistician or independent data analysis centre
  • Issues recommendations to the sponsor (which the sponsor typically follows)
  • Operates under a charter that defines stopping rules, decision frameworks, and confidentiality
  • Common stopping rules: futility, overwhelming efficacy, unacceptable safety

Why it matters. DSMBs are required by regulators for any trial of meaningful risk and are the most important external check on trial conduct. The integrity of DSMB review depends on the integrity of the data they receive — which depends on data quality upstream.

Where Flusso fits. Limited direct interaction (DSMBs receive data through an independent statistician, not directly from sponsor systems). Indirect benefit: cleaner upstream data quality means fewer DSMB queries and fewer follow-up cycles.

Related: SRC · EDC

Definition. Three core roles in a clinical trial:

  • Sponsor — the company or institution that takes responsibility for initiating, managing, and financing the trial. Holds regulatory accountability.
  • Principal Investigator (PI) — the qualified physician (or in some jurisdictions, qualified scientist) responsible for the conduct of the trial at a specific site. Reports to the sponsor.
  • Sub-investigator — other clinicians at the site working under the PI's delegation.

In practice. A multi-site trial has one sponsor and many PIs (one per site). The sponsor delegates trial conduct to the PIs through site contracts; the PIs delegate specific tasks to sub-investigators per a delegation log.

Why it matters. This delegation chain is the primary structure of accountability in trial conduct. Regulatory inspections trace responsibility through this chain; protocol deviations are attributed through this chain.

Where Flusso fits. Out of scope as a regulatory structure, but the sponsor-side operational view of "what every site is doing right now" is exactly what Flusso provides through site activation and enrolment dashboards.

Related: Site activation · Sponsor-investigator

Investigator-initiated trial (IIT)

Definition. A clinical trial designed and initiated by a clinical investigator (typically an academic clinician at a hospital or research institution) rather than by a pharmaceutical sponsor. The investigator becomes the sponsor-investigator and assumes regulatory accountability. Pharmaceutical companies often support IITs by providing the investigational product, sometimes also providing funding, but they don't run them.

In practice. IITs are particularly common when:

  • An academic clinician has a hypothesis worth testing in a specific patient population
  • The pharma sponsor doesn't want to commit to a full sponsor-led trial
  • Exploratory or proof-of-concept indications need testing before pharma commits

The Adagene / NUH Singapore IIT (NCT06846268, neoadjuvant CRC, led by Dr. Yong Wei Peng) is a typical example.

Why it matters. IITs are operationally messy from the pharma sponsor's perspective: they don't sit in the sponsor CTMS, they generate data outside the sponsor's standard pipeline, and they can produce results (positive or negative) that the sponsor needs to react to without owning the data flow.

Where Flusso fits. IIT visibility is one of Flusso's strongest fit areas. A pharma sponsor supporting multiple IITs typically has limited operational visibility into them. Flusso's coalition / cross-institutional model is built for exactly this — surface IIT progress to the sponsor without disrupting the investigator's autonomy.

Related: Sponsor-investigator · Site activation

Definition. An individual investigator who is also the regulatory sponsor of the trial — typically the role assumed by the principal investigator in an IIT. Combines the PI role and the sponsor role in one person, with full regulatory accountability for trial conduct.

In practice. Sponsor-investigators are common in academic medicine and early-stage exploratory trials. They typically have institutional support (an institutional clinical trials office, often) but the regulatory accountability sits with them personally.

Why it matters. From a pharma's perspective, the sponsor-investigator structure means the pharma is supporting not running the trial — a fundamentally different operational and risk posture than a sponsor-led trial.

Related: IIT · PI

HREC / IRB / Ethics Committee

Definition. Independent ethics review boards that approve and oversee the ethical conduct of clinical trials at a site or institution. The names vary by jurisdiction:

  • IRB (Institutional Review Board) — US
  • HREC (Human Research Ethics Committee) — Australia
  • REC (Research Ethics Committee) — UK
  • Ethics Committee — generic / EU
  • IEC (Independent Ethics Committee) — international standards term

In practice. Every clinical trial site needs ethics approval before it can enrol patients. Approvals are granted per-site (single-site review) or per-trial (central review, increasingly common). The ethics committee reviews the protocol, informed consent forms, investigator brochures, and other materials, and grants approval (often with conditions).

Why it matters. Ethics approval is a non-negotiable prerequisite for site activation. Delays in ethics approval directly delay site activation and therefore enrolment. In multi-jurisdictional trials (US + EU + APAC), the variation in ethics-review timelines can be a primary driver of cycle time.

Where Flusso fits. Ethics approval status is a tracked attribute in trial management. Flusso surfaces approval status across sites in real time, making the bottleneck visible to operations and finance.

Related: Site activation · Protocol amendment

Site Management Organisation (SMO)

Definition. An organisation that manages clinical trial sites on behalf of the sites themselves — typically a network of sites under common operational management. Distinct from a CRO, which manages trials on behalf of sponsors.

In practice. SMOs are common in:

  • Markets where sites are commercially fragmented (parts of APAC, Latin America)
  • High-volume site networks supporting multiple sponsors
  • Specialised therapeutic areas where site networks have particular expertise (oncology, rare disease)

Why it matters. SMOs add an additional coordination layer between sponsor and site — they aggregate site reporting, standardise site practices, and act as a single point of contact for sponsors with multiple sites in their network.

Where Flusso fits. Out of scope as a structure, but Flusso's multi-site visibility model handles SMO-organised sites identically to direct-sponsored sites.

Related: CRO

Contract Research Organisation (CRO)

Definition. An organisation that provides clinical trial services to sponsors on a contract basis — covering trial design, site selection, monitoring, data management, regulatory affairs, biostatistics, medical writing, and pharmacovigilance. CROs range from full-service global organisations (IQVIA, Parexel, ICON, PPD/Thermo Fisher, Labcorp Drug Development, Syneos) to specialists (oncology-focused like Novotech, regional players, niche-therapeutic-area firms).

In practice. A typical small-to-mid-cap biotech outsources 60-90% of trial execution to CROs. The CRO often hosts the operational systems used to run the trial (Oracle CTMS is commonly CRO-hosted), and the CRO's project management team is functionally an extension of the sponsor's operations team.

Adagene's hybrid model — internal clinical teams plus CROs such as Novotech — is typical of small-cap biotechs running global oncology trials.

Why it matters. CRO-hosted systems are the "other side of the firewall" from the sponsor's own systems, and bridging that firewall is a primary source of operational fragmentation. CRO data extracts arrive on the CRO's cadence (often weekly), in the CRO's format, into the sponsor's environment for stitching.

Where Flusso fits. Flusso integrates with CRO-hosted systems via standards-based APIs and CDISC exports. The sponsor sees a unified view that includes CRO data alongside sponsor-side data, without renegotiating CRO contracts or asking CROs to change their workflows.

Related: CTMS · Source Data Verification (SDV)

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