Clinical trials account for nearly half of the R&D expenses of pharmaceutical and medical device companies. Clinical trials are highly collaborative processes orchestrated across a value chain of Sponsors (drug and device makers), Contract Research Organizations (CROs), Site Management Organizations (SMOs) and Research Sites (hospitals, clinics). Efficient communication of clinical protocols, patient data and regulatory events between these organizations is critical for successful and timely launch of the new drug or device. The Net.Orange Clinical Research solution facilitates rapid information flow across the Clinical Research value chain and provides decision support tools that improve the performance of each member in the chain.
The are many challenges across the paticipants of a clinical trial. Net.Orange solutions for Clinical Research address the challenges faced by Sponsors, CROs and SMOs, and Sites.
Sponsors
The pharmaceutical industry is witnessing an unprecedented productivity drop and facing several stiff challenges. In the US, during the last decade, new drug introductions have been cut in half while R&D costs have doubled. Recent advances in genomics and in the science behind diseases have led to a ten-fold increase in the number of therapeutic targets that need clinical trial validation.
As a result, pharmaceutical companies are faced with the daunting task of conducting more clinical trials in each therapeutic area, with substantially reduced budgets.
Forecast patient accrual accurately
Track patient enrolment across multiple sites
Spot and manage potential delays before they become severe
Immediate visibility to early safety and efficacy trends to support holds/go/no-go decisions
Support and manage the increasing adopted trend of global CRO outsourcing
Capture clinical data electronically (EDC) and tie EDC systems directly to internal clinical data management (CDM) systems
Near-time access to clinical trends required to support "adaptive" trials
CROs and SMOs
Pharmaceutical companies are increasingly outsourcing protocol design, patient recruitment and data analysis to these organizations. In the last four years, CRO spending grew at 15% CAGR compared to 11% sponsor cost.
CROs and SMOs often work with multiple sponsors, with different clinical data management/ and electronic data capture (EDC) systems, and multiple sites, with different medical record systems. A major requirement for a clinical trial management system (CTMS) is to be able to interface with disparate systems at both ends of the value chain.
Automatically screen subjects based on study criteria for on-time enrolment
Plan and co-ordinate milestones and resources spanning the central administrative organization, multiple research sites, labs, and several local IRBs.
Generate realistic budgets, transparent costing and automated invoicing
Report Adverse Events automatically and manage regulatory submissions
Deploy EDC forms from different sponsor systems seamlessly
Compile the case report form (CRF) electronically
Provide sponsors with real-time access to valuable information on enrolment and patient responses
Sites
At a typical research site, regular patients are often treated side by side with research subjects by the same clinical personnel. Compiling clinical trial documentation and EDC forms can be quite time consuming and different from the processes used for regular patients. CROs and SMOs often work with multiple sponsors, with different clinical data management/ and electronic data capture (EDC) systems, and multiple sites, with different medical record systems.
Interface medical record systems (EMR), imaging and lab systems to compile source documentation for research patients
Interface medical record systems (EMR), imaging and lab systems to compile source documentation for research patients
Automatically screen subjects based on study criteria
Integrate research EDC forms within existing processes for clinical data capture
Separately handle claims processing, patient co-pays and research invoices for sponsors or CROs or SMOs.
The Benefits
Net.Orange solutions benefit everyone in the clinical research value chain. Benefits include:
Meet and exceed patient accrual targets and performance incentives
Manage study costs through on-time enrolment
Faster study setup by integrating protocols, budgets, milestones and invoicing
Hybrid mode operation helps organizations migrate from paper to EDC
Reduce costly regulatory violations by Instantly tracking clinical events such as Adverse Events and triggering IRB notifications
Configure value-added sponsor portals for quick summary view of enrolment and clinical results
Comprehensive reporting and custom dashboards
Seamlessly integrate charts and medical records from site EMR systems and Labs into case report forms
The Products
As illustrated on the Challenges tab, Clinical Research has some very unique needs to truly capitalize on opportunities for improvement. Our cOS for Clinical Research solution is delivered by pairing research-applicable products with the cOS (Clinical Operating System)™:
cOS Images provides an extensive platform upon which to base your PACS needs. cOS Images is the integrative image management solution for your hospital or clinic.
cOS Records allows practices to maintain current and complete electronic health records for patients that can be accessed from any computer. Being a full featured application, it includes many easy to use features such as clinical notes, e-prescriptions, disease templates and connectivity to billing that bring countless benefits to physicians and staff, as well as patients.
cOS Profiles is an innovative personal health profile product that leverages the extensive functionality of the cOS to create a patient-centric paradigm for managing patient data. Using cOS Profiles, you can now report, review, and act on that data from a centralized view.
cOS™ Trials is a multi-site HIPAA and FDA 21 CFR Part 11 compliant, integrated system that enables clinical research organizations to:
Insights into Clinical Research Technology
We believe that technology processes are best served by keeping up with leading industry thought, and have collected the resources below to help you make the best decisions on implementing new processes or technology into your environment.
