Hosting a Clinical Data Management system at a 3rd Party Vendor
May 18, 2006 (Press Release) --
Clinical Data Management Systems (“CDMS”) tracks the case report form (“CRF”) data completed by investors on clinical trials during the various phases a drug company is testing a new drug to fulfill FDA approvals and protocols. CDMS try to be all things to all departments while wrapping technology around a solution that changes with every trial.
CDM systems can cost well into the hundreds of thousands for licensing fees, implementation costs, help desk support, and upgrades. Although most of these fees are unavoidable, hosting greatly helps ease the pain of yearly maintenance required to run these system; a saves that adds up quickly. Consulting firms that offer hosted environments take care of the staffing as well as hardware maintenance for you and at a much lower cost monthly fee than an in-house solution.
Instead of burning through the venture capital, different levels of hosted environments are available from clinical consulting vendors for efficiency-conscious clinical firms. A hosted environment is a secured and validated environment with a full set of systems and support services from technical and functional experts housed externally from the client. A reputable full-service consulting firm will include help desk support. With this option, all overhead costs translate into low monthly fees, allowing firms to budget their expenses while easing cash flow. This option also alleviates management of additional resources, upgrade worries, training issues, and hardware maintenance.
The two types of client solutions available are called "shared" and "dedicated” as named from the hardware environment in which they reside.
The main difference between these two is the hardware environments. Of the two options, the “shared” environment will yield the highest savings. Consultants speed deployment by executing only the test cases pertaining to the cloning action of the database. In the “shared” option, the entire environment has previously been through full validation and testing prior to cloning, thus alleviating the need to perform the IQ, OQ phases again. These phases are predominantly the most time consuming phases of implementation. Upon cloning, the system requires only minimum PQ execution to be considered validated. Along with the monetary savings, installation is completed in record breaking time, one week.
Dedicated environment clients have more control over hardware decisions. However, this option requires a larger investment purchasing hardware and consulting time. Clients also may "feel" more secure about their database information. They have full control over which application versions are implemented. The most advantageous benefit in selection is that clients can move their servers in-house when they are ready and have the infrastructure to support the system. One disadvantage is that full validation must be performed, taking about six weeks to complete.
CDM systems can cost well into the hundreds of thousands for licensing fees, implementation costs, help desk support, and upgrades. Although most of these fees are unavoidable, hosting greatly helps ease the pain of yearly maintenance required to run these system; a saves that adds up quickly. Consulting firms that offer hosted environments take care of the staffing as well as hardware maintenance for you and at a much lower cost monthly fee than an in-house solution.
Instead of burning through the venture capital, different levels of hosted environments are available from clinical consulting vendors for efficiency-conscious clinical firms. A hosted environment is a secured and validated environment with a full set of systems and support services from technical and functional experts housed externally from the client. A reputable full-service consulting firm will include help desk support. With this option, all overhead costs translate into low monthly fees, allowing firms to budget their expenses while easing cash flow. This option also alleviates management of additional resources, upgrade worries, training issues, and hardware maintenance.
The two types of client solutions available are called "shared" and "dedicated” as named from the hardware environment in which they reside.
The main difference between these two is the hardware environments. Of the two options, the “shared” environment will yield the highest savings. Consultants speed deployment by executing only the test cases pertaining to the cloning action of the database. In the “shared” option, the entire environment has previously been through full validation and testing prior to cloning, thus alleviating the need to perform the IQ, OQ phases again. These phases are predominantly the most time consuming phases of implementation. Upon cloning, the system requires only minimum PQ execution to be considered validated. Along with the monetary savings, installation is completed in record breaking time, one week.
Dedicated environment clients have more control over hardware decisions. However, this option requires a larger investment purchasing hardware and consulting time. Clients also may "feel" more secure about their database information. They have full control over which application versions are implemented. The most advantageous benefit in selection is that clients can move their servers in-house when they are ready and have the infrastructure to support the system. One disadvantage is that full validation must be performed, taking about six weeks to complete.
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