Quality Data Services: Comprehensive Services for eClinical Trials

Quality Data Services: Comprehensive Services for eClinical Trials

The acceptance of electronic submissions of clinical study data and stringent regulations that mandate standardization has led to a need for advanced, user-friendly data collection tools and eClinical trial management systems. According to MarketsandMarkets report, the global market for eClinical trial solutions is projected to reach $7.61 billion by 2022, driven by the pressure on pharmaceutical companies, healthcare providers, and research organizations to accelerate the processes for clinical trial studies and contain costs. Providing true partnership to the players in the mushrooming clinical trial landscape, Quality Data Services (QDS) offers a comprehensive suite of clinical management, monitoring, data and safety management, biostatistical analysis and reporting services. “QDS guarantees consistent and personalized service from your project’s inception to completion through our dedicated staff that is accountable for superior oversight and facilitation, along with prompt communication,” says John Paige, Director of Information Technology, QDS.

QDS’ flagship product QDR, a fully integrated eClinical suite includes electronic data capture (EDC), clinical trial management (CTMS), pharmacovigilance (PV), e-diary (PRO), and interactive web randomization (IWR) systems. “We work closely with our client’s protocols to implement customized trial design and insure CDISC compliance in our user-friendly system that is simple to navigate, yet at the same time provides superior functionality,” states Paige. QDR allows for quick implementation of clinical trials, from final protocol to a live database in as little as three weeks, accelerating product time to market. Due to the fully integrated suite, the data sharing between the components is seamless, eliminating duplicate entry of data or multiple sources of vendor data. Researchers can use a single login for different components.

In addition to the eClinical suite, QDS offers full CRO services. QDS services and systems are governed by rigorous standard operating procedures that comply with ICH, GCP, and FDA regulations. The state of the art QDR-EDC-system conducts data review and manages queries in real time to ensure data accuracy and integrity.

Our goal is to provide cleaner data to our sponsors faster for more accurate decision making

"We create extensive automated system checks and trend reports to validate data, including that has been entered, third-party data, and data in other QDR components, and automatically provide queries to address data discrepancies,” remarks Paige. A pharmacovigilance (SAE) system is critical for any clinical trial, and with the QDR-PV, SAE reports, and supplemental safety data is secured in a tightly controlled database. The system generates regulatory reports and narratives in real time as events occur, and can be reviewed by safety-medical personnel at any time. “Our goal is to provide cleaner data to our sponsors faster for more accurate decision-making,” adds Paige.

QDS has over 20 years of experience helping clients collecting, managing, and reporting data for their clinical trials, subsequently providing insights and recommendations for better outcomes. The company has successfully completed over 750 clinical trials, which includes providing clinical services to 75 commercially available products. QDS, with its expertise in technology coupled with superior CRO services, provides advanced solutions that have been developed for the end user’s processes and workflows. The result is an intuitive system that has received positive feedback due to its ease of use.

Within the company, departments work closely together to enable streamlined communication that ensures coordination in clinical trials. This prevents miscommunication between the teams, encouraging recommendations and helps improve services. QDS has initiated QDR on a software-as-a-service basis to allow clients the option to select specific functions they require, from its integrated suite of clinical trial services. “We deliver unparalleled quality services, consistently delivered on time, and within budget,” concludes Paige.
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