JeanMarie Markham, President & CEO
Apart from designing and annotating case report forms and databases, a clinical data manager acts as a “middleman” between project management, the client, site, and other team members. In today’s digitized environment, data managers are looking for integrated clinical data and trial management systems and electronic trial master files to effectively overcome risks and standardize clinical research data. In such a scenario, managers need a single platform that can efficiently collect, analyze, and report clinical data. This is where Clinlogix comes in.
“We acquire data via real-time data collection, electronic medical records, big data, safety databases, imaging and other core lab databases. Data is also collected through CTMS and eTMF databases to accelerate and facilitate study management,” begins JeanMarie Markham, President and CEO, Clinlogix. The company integrates these data management systems to produce meaningful data and reports for the end users. Leveraging the trend of cloud computing, Clinlogix is researching for a better understanding of benefits and risks, in order to engage regulators through which cloud computing services can be determined.
Clinlogix has developed a ‘custom’ approach for trial execution to meet the needs of the individual clinical development program. The company works with a complete complement of Standard Operating Procedures (SOPs) that are high-level adaptable services along with robust features to clear regulatory scrutiny. “This foundation is laid early in our Project Management and Communication plans that clearly delineate roles and responsibilities, communication pathways, and escalation process for unresolved issues,” adds JeanMarie. “We understand the needs of the clinical study network, including inventors, who study molecules through animal testing, and clients who have marketed products and are learning products safety.”
The company’s diverse team is comprised of industry experts in medical device and pharmaceutical services across multiple therapeutic areas. Their cross-functional teams include project management, programming, biostatistics, data analysts, and dictionary coding experts.
We thrive to provide organizations with the knowledge and assistance required for regulatory compliance, supply chain, efficiency, and electronic data management challenges
Additionally, Clinlogix’s data managers perform quality assurance over the database build, participate in the design and fabrication of the electronic case report form, as well as monitor and clean the data. With the most experienced eMonitoring and project teams on board, Clinlogix offers wide range of services within the company’s Electronic Data Capture systems (EDC) and clinical paper trial system. “We offer effective trial sup¬ply management, electronic data transfer, robust reporting capabilities, eCRF design and review, automatic plausibility checks, and query tracking to better suit client’s requirements,” says JeanMarie. The company also utilizes Oracle’s Argus safety technology, a gold standard for adverse event capture, analysis, and reporting. “Our safety reports significantly meet regulatory compliance requirements and are meaningful to IRBs, clients, partners, and others during their review,” explains JeanMarie.
In one such instance, Clinlogix was instrumental in collaborating and orchestrating one of the early PMDA or FDA submissions for a medical device. This entailed harmonizing a protocol and subsequent required datasets in order meet the regulatory requirements and rigor of both the PMDA and the FDA. The end result was a timely approval of the device by both agencies.
Being a customer-first company, Clinlogix provides productive support to their clients during the planning, execution, and closeout of their study. Assisting in market assessments for investigational products, the company helps clients to find patient populations that best fit their inclusion or exclusion criteria along with regulatory filing process. Forging ahead, the company is planning to expand their global team for providing more effective internal resources to clients. Clinlogix continues to build a tremendous network of international key opinion leaders, study investigators, CRAs, project managers, and study coordinators to empower their clients.