Clinical trials
Clinical trials: Clinical trials that stay safe and on schedule, from depot to dose
Real-time temperature monitoring automatically alerts for excursions in transit, before your investigational product reaches the hub or site, protecting both participants and timelines. Devices, platform, and 24/7 response, managed as one service.
In clinical supply, a late IMP delivery is a missed visit
If a kit is held while an excursion is investigated, the participant can't always come back tomorrow. The visit falls out of window, the protocol deviates, and the study slips.
Delay and cost figures from the Controlant white paper “Preventing costly delays in clinical trials via real-time shipment tracking”.
- of clinical trials are delayed by at least one month
- 80%of clinical trials are delayed by at least one month
- typical cost of a one-month delay in lost market exclusivity
- $18M+typical cost of a one-month delay in lost market exclusivity
- longer than planned for many delayed Phase III trials
- 3 to 6 monthslonger than planned for many delayed Phase III trials
The challenges
Six points between depot and IMP dispensing where a study loses time
Clinical shipments
Clinical shipments
A lost IMP kit is hard to replace
Kits are made in small batches, with randomization codes set in the RTSM. Every damaged box is slow and costly to resupply.
Our solution
A reusable Saga device on every shipment, tracking condition and location from the depot.
Clinical shipments
Customs delays surface too late
A passive logger can't show a hold at customs. By the time the data is read at site, it is too late to act.
Our solution
Your team sees a shipment held at customs as it happens, and our MARS team acts with your forwarder, 24/7.
Clinical shipments
Receipt starts an email chain
Staff read out passive loggers, file reports, and wait for quality to approve. A Friday email may wait until Monday.
Our solution
Scan the QR code to get the delivery report. No platform login needed.
IMP kits that arrive in range are released automatically.
Clinical shipments
Single-use loggers end up as waste
Clinical shipments repeat the same routes, and a single-use logger is thrown away after every trip.
Our solution
We collect, recharge, and recalibrate our devices for the next shipment.
Clinical storage
Storage checks are manual and periodic
Every site stores IMP differently, and a logbook says nothing about the hours between checks.
Our solution
Saga devices record every 10 minutes and report over the cellular network on a set schedule, from hourly to daily, and at once on an excursion. No USB downloads.
Clinical storage
IMP quarantine delays participant visits
While an excursion is reviewed, the kit can't be used and the participant can't always come back. Missed visits become protocol deviations.
Our solution
Your RTSM blocks the affected kits. QA releases them back to stock.
What a managed solution means
One end-to-end managed service, not just another device
Devices, platform, and people run as one service. We handle the complexity, so your clinical supplies team sees the status of every kit and only hears from us when something needs a decision.
Services
The team that stays on it with you.
- Device managementReturns and inventory
- MARS24/7/365 monitoring
- ImplementationPilot lane to global
- TrainingRole-specific
- AnalyticsLane and excursion
- Support24/7/365 global
The Controlant Platform
Every IMP kit in every study, across the globe, in one view
Saga devices, third-party loggers, and carrier milestones in one GxP-validated record, shared with the people who need it.
- Status of every kit by study, depot, and site
- Alerts by SMS and email, routed by role
- Access for site staff and partners without an account
- Integrates with RTSM, eTMF, ERP, CTMS, and more
- GxP validated
- 21 CFR Part 11
- EU GMP Annex 11
- Validated Integrations API
Global teams are aligned
Sponsor, CRO, and depot work from live shipment data, so decisions move fast and in sync.
Sponsor
Global Clinical Supplies Manager
Needs to know every kit is fit to dispense, in transit and at site, without waiting on sites to report.
- Investigate before the kit arrives
- Fewer resupply orders and less RTSM reprogramming
- Resupply decisions based on data, not caution
CRO
Clinical Project Manager and CRAs
Owns study delivery, site oversight, and inspection readiness across countries and sites.
- Temperature records reviewed remotely, so site visits go to investigators
- Study-status reporting from real data
- Audit-ready records by default
Depot and logistics provider
Global and regional clinical distribution hubs
Stores and distributes investigational product for several sponsors and studies.
- Shipments created automatically
- Every storage point on one dashboard
- Evidence for sponsors without manual reports
RTSM and IRT integration
Your RTSM decides what gets dispensed. We tell it whether it's safe to
Step 1: Excursion detected
A Saga device reports it, and MARS starts working it in real time.
Step 2: Kit numbers are quarantined in RTSM
The affected kits can no longer be dispensed, within minutes and with nothing for the site to do.
Step 3: QA decides on evidence
Controlant data, the impacted kit list, and the event timeline arrive together.
Step 4: Affected kit numbers are available in RTSM to dispense
QA's release puts them back in the RTSM, with no manual re-entry.
- No change to the site workflow
- Blinding preserved: only condition and status cross the interface
- GxP-validated, rolled out study by study
Integration scope and timelines are agreed per RTSM provider and study.
If you have participant visits planned for randomization or their next dose, but the IMP can't be administered because a temperature excursion is being investigated, you can't always say, ‘Come back tomorrow.’
White paper
Preventing costly delays in clinical trials via real-time shipment tracking
How real-time visibility of investigational product in transit and in storage protects participant visits, study timelines, and market exclusivity, with seven recommendations for where to start.
Keep your next trial on schedule
We will walk through your trials, your sites, and where excursions are costing you participant visits.