Nubilaria Clinical Data Management

Nubilaria Clinical Data Management Services

In the pharmaceutical industry, keeping up with technological advancements is crucial. Unified platforms are necessary to address the challenges of integrating multiple data sources in clinical data management (CDM).

OVERVIEW

The role of data managers has evolved into that of a data scientist, and as a result, pharma companies are placing more emphasis on data integrity and the use of next-gen electronic data capture (EDC) tools, data warehouses, and non-CRF data integration in clinical trials. At Nubilaria, our data managers have evolved into clinical data scientists who perform trend analysis with increased scientific rigour and real-time data reviews using advanced analytics to keep pace with these expectations.

SOLUTION

Nubilaria’s CDM services aim to deliver high-quality clinical trial data. Given the pharmaceutical industry’s evolving needs, we offer standards-driven CDM services, innovative study builds, direct data transfer to EDC, and intelligent queries with risk-based data management. Our study start-up services cover developing a data management plan, eCRF specifications, edit check specifications, database design, edit check programming, external checks or listing programming, case report form (CRF) completion guidelines, quality control management, and user acceptance testing.

Nubilaria adheres to coding guidelines for WHODrug Dictionary (WHODD) and MedDRA, undertaking essential dictionary set-up tasks to ensure compliance in our processes. Our study conduct services suite covers data review and query management, data entry and verification, third-party data transfer and reconciliation, ePRO data handling, medical coding, SAE reconciliation, medical data review, study data transfers, archival, etc. In the study closeout phase, we collaborate closely with customers and offer support for database and regulatory audits, interim database closure and lock, project closure documentation, study data transfer, archival, and decommissioning.

In addition, Nubilaria offers speciality services, such as automation consulting, technology-led digital clinical trials (DCT) services, innovative questionnaires (ePRO, e-diaries), smart devices and wearables, and medical device data management proficiency. Customers can opt for an end-to-end study-based, milestone-based, or FTE (full-time equivalent) model, tailoring our approach to a study’s unique needs. Collaborative synergy across domains like clinical operations, biostatistics programming, and medical writing has delivered superior data outcomes.

BENEFITS

We offer a holistic approach to quality and compliance with an inspection readiness team. We use an agile methodology, with practices such as collective work management, transparency, real-time interventions, and collective wisdom, to drive quality and efficiency. We prioritize a first-time-right (FTR) approach and embrace change.

Nubilaria’s CDM projects have delivered upper-quartile performance by significantly reducing median cycle times (for the final protocol to go live and the last-patient-last-visit to database lock).

THE NUBILARIA ADVANTAGE

Nubilaria drives transformation through technology innovations and industry-standard solution accelerators. Our deep domain expertise in CDM spans two decades, including projects for multiple top global pharmaceutical companies. Our experienced talent pool reflects knowledge depth across phases I to IV, experience handling clinical studies with complex disease indications. Our agile, lean, experienced, and adequately resourced teams assure delivery excellence commitments by mitigating risks and challenges.

Our leadership position in capability and experience in the life sciences domain, IT, and R&D brings unique transformative solutions to the CDM landscape. We have rich technical expertise with unified platforms, reporting tools, electronic clinical outcome assessments, drug management system. These complement our proprietary solutions to provide end-to-end CDM services.

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