Data Operations

Governed by Quality Assurance in Clinical Trials

Minerva Research Solutions is the leading clinical operations support provider in data management for the clinical research industry. We offer a variety of services, one of which is data operations. We aim to enhance sponsors’ and pharmaceuticals’ overall experience by providing quality scientific data, with minimized queries.

Our quality assurance in clinical research activities is delivered by experts who take into account a monitor’s requirements while at the same time developing solutions that maintain GCP compliance. Our data operations team remains in close contact with the sponsors and responds to the queries generated within 24 hours. Providing quality & clean data reduces the chances of errors and ensures sponsors’ timelines are being followed.

— Quality Assurance in Clinical Trials

Data Management in Clinical Research

Our data operations team includes a separate quality assurance department that facilitates the data entry team—whose primary goal is to ensure the delivery of quality and clean data. The quality assurance team is responsible for data entry into EDC after stringent quality checks.

Our data management in the clinical research process is efficient and the data is entered within 24 hours. In case a query pops up, our teams strive to resolve it within the next 24 to 48 hours. We also offer E-source template development as per the eCRF guidelines provided by the CROs and Sponsors we work with. Minerva Research Solutions’ goal is to exceed the industry timeline and deliver data with complete data protection of the subject’s sensitive information.

Insights into Our Extensive Data Operations Solutions

Solutions that provide security, capability, and GCP compliance to enhance CROs & sponsors’ experience.

Implementing & Ensuring

Quality Assurance

The role of quality assurance is to make sure the data in a clinical trial is error-free and accurate.

Pre-qualifying Participants

Pre-Screening

Qualifying potential participants to participate in clinical research as per study criteria requirements.

Expertly Developing

Templates & e-Source

By stringently following the study protocol & eCRF guidelines, we develop e-Source & templates for your study.

Ensuring Quality Assurance

Micro Quality Check

Micro quality checks help minimize errors and ensure the delivery of quality & clean data to sponsors.

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Have questions?

How does the data operations team help in data management in clinical research?

The data operation team plays a huge role in the management of scientific data. They ensure quality assurance in clinical trials through meticulous checks of patients’ data while at the same time complying with GCP and FDA guidelines, and fulfilling the requirements of the sponsor.

How do you ensure the data is cleaned and thoroughly reviewed?

Our process of quality checks in data operations is devised to ensure that the data is thoroughly cleaned and checked and there are no disparities in the data delivered. For this, we have two separate teams. One is the data entry team whose job is to ensure that the data is uploaded on RealTime. The other team is the quality assurance team whose main goal is to verify that the data uploaded in RealTime is clean, error-free, and complete before it is uploaded onto the EDC or sponsor’s portal.

What software is used in the whole process?

Minerva Research Solutions has its own portal that is solely for the CRC’s use—ensuring that the site is ready for study startup (logistics). The other software that we use to upload participant data before entering it into the EDC is RealTime-CTMS. Currently, we are working on developing more software for sponsors to efficiently manage clinical trial operations and the data entry process.

What capabilities does our data operations team possess?

Our data operations team has extensive experience in patient data management on various software. With the help of our data operations team, the data is entered into the portals and managed painstakingly to ensure clean & quality data.

Discoveries & Expertise that leads to Efficient Data Management in Clinical Research.

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