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  • Detroit Clinical Research Center - Home
    supports clinical research studies across all hospitals and medical facilities in South Mid and East Michigan DCRC also collaborates with other health institutions in Michigan North America and Internationally to support leading health care research projects Detroit Clinical Research Center PC A Mission for a Cure 2011 About us Focus on Quality Focus on Innovation Focus on IT Six Sigma Advantage Our Services Site Management Biostatistics IRB Lab Services Data Management Regulatory Services Feasibility Studies Volunteers Trial Information Investigators FAQ Enrollment Requirements Career Join our Team Contact us Contact DCRC Volunteer for a study A clinical research study is conducted by qualified doctors to evaluate a new investigational treatment for a certain illness Before any investigational treatment is given to subjects in a clinical research study it is researched in a laboratory Clinical research studies provide a way to test experimental treatments Every widespread treatment today has been proven safe and effective in a clinical trial Our Services DCRC adheres to the highest standards of quality and ethical conduct with the safety of patients and volunteers as a top priority DCRC follows centralized and streamlined processes to conduct studies in efficient ways that reduce costs and save time and resources

    Original URL path: http://www.dcrc.us/ (2016-04-25)
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  • Detroit Clinical Research Center - About us
    experience in the delivery chain The first gap is in processing initial feasibility Research Protocols are complex demanding resource intensive and disruptive to daily health care providers Sponsors and CRO s expect Sites and Investigators to process increasing amounts of data and inquiries prior to the consideration of a site and they expect these services to be provided free of charge Faced with limited resources or uncertainty regarding the implications of the research protocols Investigators either reject participation or agree to participate without realizing the expectations of the research project and postpone the actual decision after charging the sponsor initial start up fees The second gap is the availability of experienced site resources except for established academic institutions sites cannot afford to devote specialized staffing for research Research projects are unique and complex and require staff with a strong understanding of regulatory IT budget and quality implications of these projects The third gap is in budgeting Most clinical trial budgets are unrealistic and overly detailed overpaying for certain items or ambiguous hiding some other items Sponsors and CRO s mistakenly assume that when sites approve the budgets they will deliver the project Sites and doctors realize the implications of the budget assumptions soon after launch and if the grants are not realistic they simply stop the study a big loss for Sponsors not only for the costs already incurred but also for the opportunity cost The fourth and most important gap is in patient accessibility screening recruiting and support Most sites and PI s do not have such expertise or resources How we can help you We can assist you as a regional Site Management Organization DCRC has access to hundreds of doctors and sites in all therapeutic areas Most of the doctors trust our evaluation to the study and

    Original URL path: http://www.dcrc.us/pages/about-us.html (2016-04-25)
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  • Detroit Clinical Research Center - Focus on Quality
    The TLGs that are generated as part of a statistical analysis of the data are also inspected to ensure their accuracy as is any text in a CSR that refers to the TLGs QA activities The QA activities to be conducted during a specific clinical trial are included in a QA audit plan These activities include the number of investigator sites selection criteria and vendors to be audited such as labs and drug packaging and distribution providers This plan also specifies what internal processes of the study will be audited from initial study design site and data management statistical analysis and the final CSR It specifies audit team members and auditees for each study stage as well as the standards against which the audit will be conducted such as the protocol CRF completion guidelines SOPs ICH GCP guidelines and FDA regulations Audits must also consider the standards of countries other than the United States such as the recently adopted EU Clinical Trial Directives 2001 20 EC and 2005 28 EC 5 A thorough QA audit plan also clearly states the documents to be provided by the auditees as well as the location date and expected duration of the audits Preparation for QA audits should include review of the approved protocol and amendments SOPs both general and study specific any specialized training associated with the study annotated CRFs and the statistical analysis plan SAP Internal process audits are another important QA responsibility Internal audits review all the drug development processes employed across several studies to determine if there are systemic problems This includes a review of employee training compliance with SOPs and regulatory requirements and documented evidence that QC was appropriately conducted on the output of each internal process as well as the final deliverable to a client Site management metrics Internal audits of the site selection and management processes ensure that qualified investigators are selected that they have adequate facilities and adequately trained staff and that the study was conducted in compliance with the protocol and all appropriate regulations 3 Several metrics commonly evaluated by internal process audits after the study has begun include Percentage of monitoring visits completed on time Percentage of evaluable subjects no protocol violations Percentage of serious adverse events SAEs reported within 24 hours to an Institutional Review Board IRB and sponsor Percentage of properly executed informed consent forms Number of queries CRF pages reviewed Number of missing data entries CRF pages reviewed Computer Systems Validation Computer systems validation examines all aspects of the data handling computer systems hardware and software to ensure the accuracy reliability consistent intended performance and the ability to discern invalid or altered records This includes initial installation and procedures that document how changes to a computer system are justified approved and implemented The validation process begins with examining user requirements the results of the initial hardware installation qualification IQ tests the operational qualification OQ tests and the qualification and training of user personnel The user acceptance test results Performance Qualification are

    Original URL path: http://www.dcrc.us/pages/focus-on-quality.html (2016-04-25)
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  • Detroit Clinical Research Center - Focus on Innovation
    Services Feasibility Studies Volunteers Trial Information Investigators FAQ Enrollment Requirements Career Join our Team Contact us Contact DCRC Home About us Focus on Innovation Innovation At DCRC we realize that innovation is the engine of the Bio Pharmaceutical Industry We strive to use the most innovative tools and approaches Innovation in product development DCRC is actively involved in assisting our clients with the development and incubation of strong early on candidates for therapeutic products We partner with several leading pre clinical companies to assist in bringing new therapies to market Innovation in processes We are process oriented and we strive to standardize our processes to avoid repletion and streamline the conduction of projects We are able to treat each project and each client uniquely To do so we implement commercial and in house web based processes to tailor IT solutions to our clients projects needs Innovation in tools We use several six sigma tools to support our activities and innovatively select the appropriate application that fit into specific projects In products optimization we use discrete computer based choice models to optimize outcomes of the research projects and predict behaviors of patients and practitioners We also have the capability to utilize

    Original URL path: http://www.dcrc.us/pages/focus-on-innovation.html (2016-04-25)
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  • Detroit Clinical Research Center - Focus on IT
    deliveries happen on time with the highest data standards EDC Electronic Data Capturing EDC was first started in 1998 ever since it is being used by many clinical research companies EDC captures data electronically so it helps us get the information fast and it offers great potential for improving the clinical development process and bringing products to market much faster when compared to the manual paper based data management Advantages of EDC Online data collection Monitoring and processing through internet connectivity to a secure central database New devices like PDA and tablet computers can be used We can generate data while testing and while data is being collected Easy access from anywhere without having to sacrifice the patient security and privacy Accurate and reliable data Reduces the drug cost by streamlining development functions Products reach the market sooner Electronic submission enables pharmaceutical companies to speed up approval process Redundancy is eliminated and errors are avoided Interactive voice response which is being used for almost a decade now will have an enhanced version Analysis and reports of clinical trials could be accessible by physicians and researchers in no time Electronic submission enables pharmaceutical companies to speed up approval process Redundancy is eliminated and errors are avoided Interactive voice response which is being used for almost a decade now will have an enhanced version Analysis and reports of clinical trials could be accessible by physicians and researchers in no time What we offer We can provide our expertise in the following EDC implementation areas Electronic Data Capture Feasibility Analysis of implementing EDC Study Site data collection methodology 21 CFR 11 requirements analysis Preparation of Data Management Plan EDC Tool selection Interface design for integration with external data sources including Hybrid approaches EDC Screen Design Edit Check identification Data Security implementation Data Interoperability

    Original URL path: http://www.dcrc.us/pages/focus-on-it.html (2016-04-25)
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  • Detroit Clinical Research Center - Six Sigma Advantage
    can be fitted It leads to a bold 3 4 defects per million The greater the number of Sigma s the most controlled the process is fewer chances of defects and higher expected profit Six Sigma The Process The Six Sigma methodology is based on a well defined roadmap divided into five main steps Define Measure Analyze Improve and Control DMAIC This tool is very efficient because it is a well organized method of asking the right questions identifying the proper inputs required to answer them and the outputs In other words it can be seen as an oriented brainstorming Improvement teams use the DMAIC methodology to root out and eliminate the causes of defects D Define a problem or improvement opportunity M Measure process performance A Analyze the process to determine the root causes of poor performance determine whether the process can be improved or should be redesigned I Improve the process by attacking root causes C Control the improved process to hold the gains Define Seek and prioritize opportunities makes the business case real identification of the problem and goal statement identify and designate The team for the project and describe the as is process customer and requirements Measure Decide what and where to measure develop and agree on operational definitions identify appropriate data source s prepare collection forms and sampling plan and test refine and implement measurement Analyze Examine process and data This is where the questions of feasibility redesign or a new design take place and the assumptions of the process are reevaluated and further analyzed as appropriate develop root cause hypothesis and investigate as well as verify the root cause Improve Generate solution ideas narrow ideas and develop proposed solutions select best solution to achieve the goal plan and test improvement solution and evaluate refine and expand proposed solution s Control Plan ongoing measurement develop appropriate and applicable documentation prepare revision and response plans and maintain as well as expand the gain Design for Six Sigma Design for Six Sigma is defined as A methodology for designing new products and or process A methodology for re designing existing products and or process A way to implement the six sigma methodology as early in the product or service life cycle as possible A way to exceed customer expectations A way to gain market share A strategy toward extraordinary return on investment In the new era competitive world new technologies will be developed and improved and will eventually be obsolete for the need of more advanced technologies In this dynamically changing world product cycles are expected to last for just a few months To meet these demanding requirements product developers have to develop products in the shortest amount of time that is safe reliable and competitive For the majority of organizations long term success is tied directly to the new product development process Tomorrow s revenue and growth are tightly bound to how successful organizations are at launching new products Understanding what aspects of a product are

    Original URL path: http://www.dcrc.us/pages/six-sigma.html (2016-04-25)
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  • Detroit Clinical Research Center - Site Management
    Lab Services Data Management Regulatory Services Feasibility Studies Volunteers Trial Information Investigators FAQ Enrollment Requirements Career Join our Team Contact us Contact DCRC Home Our Services Site Management DCRC supports studies across a large number of clinical sites across southeast Michigan In order to facilitate multi site studies for sponsors that require large patient population coverage DCRC provides a centralized process of managing and monitoring sites with a robust IT infrastructure and a staff of highly qualified individuals This enables sponsors to handle several sites at the same time with no incremental resource costs DCRC s site management services include Site feasibility and qualification according to protocol requirements On site training for the investigational team and the study staff Patient recruitment services using internal call center Archiving trial documentation and quality control Our Clinical Research Coordinators may follow either our own or the sponsor s standard operating procedures We can also use our monitoring plans and procedures and GCP online training Our monitoring activities involve feasibility and study site initiation study development monitoring and study close out at the clinical site Our staff is trained to clarify protocol issues with the investigational team handle protocol amendments review the source documents

    Original URL path: http://www.dcrc.us/pages/site-management.html (2016-04-25)
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  • Detroit Clinical Research Center - Biostatistics
    Biostatistics Our biostatistics group consists of biostatisticians and consultants who are faculty members at leading universities in Michigan DCRC collaborates with biostatisticians from other national and global research institutions and therefore can meet sponsors needs of all levels of sophistication in biostatistics services whether in study design or analysis DCRC can also assist Sponsors with expertise accumulated during years of experience in clinical research and medical care We encourage our

    Original URL path: http://www.dcrc.us/pages/biostatistics.html (2016-04-25)
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