Statking Clinical Services
Riding the Momentum of Electronic Data Capture

In the wake of digitization, clinical data management (CDM) in clinical trials has witnessed a wave of transformation from the paper case report form to electronic data capture (EDC) systems. “In recent years,we are driving towards even more personalized data entry through the use of patient reported measures and diaries that can be completed by the patients at home,” says Dennis W. King, President and CEO, STATKING Clinical Services. However, King feels that there is an extensive need to educate emerging companies on the benefits of EDC to record clinical trial data, including patient reported outcomes. To help organizations move their products faster into the market, STATKING one of the leaders in CDM technology provides a variety of clinical trial services including clinical data management, biostatistics and data analyses to the pharmaceutical and medical device industries. STATKING provides a complete, cost-effective clinical data management solution to emerging companies that are engaged in Series A or Series B funding rounds. The company has provided clinical data management services to over 150 emerging companies in the U.S., Canada, EU and Australia making it one of the leading CROs whose niche market is emerging pharmaceutical and medical device companies.

The company stays aligned with technological advancements while delivering its robust CDM solution in market. King observes that the most dominating trend in this arena is the integration of patient reported outcome measures and patient diaries into data collection. The CDM landscape experienced a buzz for handheld devices several years ago.

Today, upgraded EDC systems exist that enable home users involved in clinical trials to login to the systems and enter the data.

STATKING provides clinical data management services using its 21 CFR 11 compliant EDC system. The company uses OmniComm’s TrialMaster EDC software to develop data entry screens to capture data based on the data management plans STATKING personnel produces.

STATKING provides clinical data management services with top notch EDC software along with a host of other clinical trial services to emerging pharmaceutical and medical device companies. We are a leader in providing CRO services to emerging companies

King believes that TrialMaster is an efficient software package that is broad enough to cost effectively cover all the needs of the client for collecting data that would stand up to FDA audit.

STATKING not only has top notch software to work with but also employs highly competent people who provide data management on a level that clients can trust and depend. King informs that the company’s management is highly involved in all projects. This leads to efficient solution of CDM problems and means that timelines will be met on all projects. For instance, one of the company’s clients requested STATKING to help them form a clinical events committee and check all the adverse events observed in their clinical trials for their relation to the study devices. STATKING seized the opportunity to use the TrialMaster software to build a reporting system for adverse event adjudication. STATKING built this application and has implemented it on a number of clinical trials involving CECs. As a result, the client’s process of adjudicating the adverse events was streamlined and they now had electronic records of all CEC processes related to their study.

Though the company has various success stories with its existing services, STATKING is always looking for new solutions in the data management space that would enhance their client’s ability to move their development programs forward. STATKING has recently opened a new division that will operate as STATKING Animal Health CRO. The new division will apply the experience gained managing clinical trial data for human products to the data management for studies for new feeds, drugs and medical devices for companion and large animals.