OncologyClinical Data ManagementPhase III

Reducing Database Lock Time by 40% on a Phase III Oncology Study

Global Oncology Sponsor

40%

Faster database lock

98%

Query resolution rate

6 weeks

Submission delay avoided

01

The Challenge

A global Phase III oncology sponsor faced a backlog of 4,200 outstanding queries at the 90-day pre-lock window, threatening a 6-week submission delay.

02

The IDDCR Approach

IDDCR deployed AI Companion Tools to automate query generation and triage, combined with a dedicated CDM surge team operating across three time zones.

03

The Outcome

Database lock achieved 40% ahead of the revised schedule. Outstanding queries reduced from 4,200 to under 80 at lock. Submission timeline fully recovered.

40% — Faster database lock
98% — Query resolution rate
6 weeks — Submission delay avoided

"IDDCR's CDM team and their AI tooling turned what looked like an insurmountable query backlog into a non-event. The lock came in ahead of even our optimistic scenario."
VP Clinical Operations
Global Oncology Sponsor

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CDISC SDTM Automation Across a 12-Study Rare Disease Programme

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Neurology

End-to-End Trial Management for a 22-Country Phase II Neurology Study

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Establishing a Pharmacovigilance Signal Detection Programme for a Cardiovascular Portfolio

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Rare DiseaseCDISC StandardsPhase II / III

CDISC SDTM Automation Across a 12-Study Rare Disease Programme

Rare Disease Biotech

60%+

Reduction in programming effort

12

Studies delivered on schedule

0

Critical FDA validation findings

01

The Challenge

A rare disease biotech needed SDTM-compliant datasets across 12 studies with heterogeneous EDC configurations, facing an FDA submission deadline in 14 months.

02

The IDDCR Approach

iClinicalAI was configured to automate SDTM mapping, validation and define.xml authoring across all 12 studies, with IDDCR statistical programmers providing oversight and regulatory review.

03

The Outcome

Programming effort reduced by over 60%. All 12 study SDTM packages delivered on time. Zero critical Pinnacle 21 findings at FDA review.

60%+ — Reduction in programming effort
12 — Studies delivered on schedule
0 — Critical FDA validation findings

"The iClinicalAI-driven SDTM automation gave us a level of consistency and speed across 12 studies that would have been impossible with a traditional programming approach."
Head of Biometrics
Rare Disease Biotech

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Oncology

Reducing Database Lock Time by 40% on a Phase III Oncology Study

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Neurology

End-to-End Trial Management for a 22-Country Phase II Neurology Study

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Cardiovascular

Establishing a Pharmacovigilance Signal Detection Programme for a Cardiovascular Portfolio

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CardiovascularPharmacovigilancePost-Marketing

Establishing a Pharmacovigilance Signal Detection Programme for a Cardiovascular Portfolio

Cardiovascular Pharma

87 days

Programme go-live

99.4%

ICSR SLA compliance

0

Agency queries on first PSUR

01

The Challenge

A pharmaceutical company with a growing cardiovascular portfolio needed to establish a scalable, EMA-compliant signal detection and aggregate reporting function within 90 days.

02

The IDDCR Approach

IDDCR built and validated a signal detection workflow using disproportionality analysis, integrated with the client's safety database, and delivered the first PSUR within the agreed timeline.

03

The Outcome

Full signal detection programme operational in 87 days. First PSUR submitted on time with zero agency queries. ICSR processing SLA compliance at 99.4%.

87 days — Programme go-live
99.4% — ICSR SLA compliance
0 — Agency queries on first PSUR

"IDDCR stood up a fully compliant PV programme faster than we thought possible. Their team understood our portfolio and the regulatory expectations from day one."
Head of Drug Safety
Cardiovascular Pharma

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Infectious DiseaseBiostatisticsPhase II / III

Adaptive Design Biostatistics Support for a Phase II/III Infectious Disease Study

Infectious Disease Biotech

18 days

SAP delivery

100%

On-time interim analysis

FDA accepted

Adaptive design at EoP2

01

The Challenge

A sponsor required biostatistics support for a seamless Phase II/III adaptive design with an interim analysis, requiring rapid turnaround of the SAP and blinded sample size re-estimation.

02

The IDDCR Approach

IDDCR's biostatistics team authored the SAP, pre-specified the adaptive decision rules, and executed the blinded interim analysis in collaboration with an independent DMC statistician.

03

The Outcome

SAP delivered in 18 days. Interim analysis completed on schedule. Adaptive design accepted by FDA without modification at end-of-Phase II meeting.

18 days — SAP delivery
100% — On-time interim analysis
FDA accepted — Adaptive design at EoP2

"The IDDCR biostatistics team's expertise in adaptive designs was evident from the first call. Their SAP was thorough, and the FDA's acceptance of our design was a major milestone."
Chief Medical Officer
Infectious Disease Biotech

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