Clean Data, Clear Decisions: Accelagen’s Impact on Clinical Trial Success

Accelagen’s data management team is setting the benchmark for clinical trials by combining global standards, smart technologies, and strong sponsor partnerships. Their commitment to quality ensures faster timelines, cleaner data, and better outcomes.

The Importance of Data Quality in Clinical Trials

Data quality is a key foundation of clinical trial success. At Accelagen, a team of experienced data managers work behind the scenes to ensure that sponsors receive clean, accurate, and compliant datasets, ready for statistical analysis and regulatory submission.

One of Accelagen’s Clinical Data Manager, Anusha Adusumulli, applies her clinical data science expertise across every phase of the trial lifecycle, from database design and build through to ongoing cleaning, query resolution, and final database lock. Her team’s impact supports decision-making at every level, including the regulatory evaluation of trial compliance.

Anusha believes that supplying clean data to the statisticians is integral to clinical trial success and supporting the goal of Accelagen to accelerate human health and wellness. “We are working on patient data that is going to help regulators to decide to approve a new drug. So it is critically important for Accelagen and the data managers to provide high quality data.”

Building Reliable Databases Aligned to Protocol Objectives

The data cleaning and query management process begins as soon as the protocol is finalised. The team designs a bespoke database aligned to protocol objectives and regulatory requirements using a combination of standardised CRF library and study specific customisation. Validation rules are programmed from the start, enabling the system to flag incorrect or inconsistent entries in real time, reducing not only the risk of transcription errors but prompting corrections at the point of entry.

Accelagen distinguishes itself by prioritizing open communication among database managers, sponsors, and research sites. By encouraging regular feedback from cross-functional teams, the company is able to draw on a wide range of expertise, and ensuring the usability and integrity of the database for all users, leading to strong, collaborative clinical trial management.

Global Standards for Clinical Data Consistency

The team operates within globally accepted data standards, including CDISC, to maintain consistency and reduce post-study processing. This streamlines handover to statisticians by removing the need for field mapping or data reformatting, which can delay analysis and increase the chance of error.

Where additional logic checks are needed, reviews are conducted frequently using tools such as Power Query and SAS listings. These listings are tailored to each study’s design and allow complex data conditions to be reviewed consistently, even in high-volume trials.

Accelerating Query Resolution with Flexible Workflows

While many EDC platforms support basic validation, Accelagen’s strength lies in its layered review approach and flexible workflows. Query resolution is governed by timelines set in the study’s data management plan, which are shared with sites via CRF completion guidelines. Each query has a structured life cycle: initial issue, site response, review, and resolution. Timelines for turnaround are typically within a few days for each stage, reducing potential delays while maintaining data quality across complex studies.

However, maintaining clean data is not always straightforward or programmable. Recently, Anusha’s team worked on a study with multiple labs supplying the same data type but using different units and reporting conventions. The team resolved the issue by preparing multiple data transfer specifications and coordinating with the statistical team to develop a mapped analysis approach. Close communication and careful planning ensured the data remained consistent and usable at lock.

Sponsor Collaboration Drives Clinical Trial Success

Accelagen’s success is rooted in strong relationships and close collaboration with sponsors. The data management team works closely with clinical and project leads, external stakeholders, and, when necessary, third-party providers such as bioanalytical or pathology laboratories. Throughout the database build phase and beyond, the team actively tracks key data metrics, reviews query trends, and addresses any issues across sites or vendors to ensure smooth project progress.

Sponsors receive regular updates on data status through regular scheduled calls, which cover query resolution, source data verification (SDV) progress, and any challenges at the site level. This transparent communication helps build trust and supports informed decision-making throughout the study. When planned early, interim data reviews provide sponsors with access to important findings before database lock, aiding in strategic planning for investor communications, publications, or regulatory engagement.

Looking to the future, Accelagen is expanding new ways to increase efficiency through automation. AI-powered validation testing may help reduce the manual burden of edit check testing and database quality assurance, particularly in larger trials, although maintaining human oversight remains essential for safeguarding patient data and remaining compliant.

Trusted Partners for Complex Clinical Trials

The company’s emphasis on collaboration, quality, and adaptability has made it a trusted partner for sponsors navigating increasingly complex clinical trials. As Accelagen continues to expand its capabilities, it remains grounded in a culture that supports both its people and the quality of its service.

By bringing together flexible systems, robust processes, and a team culture focused on care and accountability, Accelagen delivers more than just clean data. It delivers trust, reliability, and the confidence that every data point will stand up to scrutiny.

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