Management Software (CTMS)
Clinexa utilizes an industry-leading Clinical Trial Management Software (CTMS) solution that is compliant to FDA and other major regulatory requirements. Our CTMS solution allows us to integrate all our clinical trial solutions at every stage of a clinical trial. We operate our processes though the least use of paper resource so that all information regarding the study is at one place with appropriate access provided to all parties involved in the completion of the study.
Through the optimum use of CTMS, we ensure the minimum use of time and effort to a significantly lower risk of documentation errors. Our clients are assured of a CTMS that provides for efficiency, productivity and the highest quality of data expected to arise from the clinical trial. We also ensure that insightful data is available to make effective decisions regarding the study, especially overcoming challenges related to recruitment, retention and budget control.
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Electronic Data Capture (EDC)
Clinexa utilizes multiple industry standard EDC platforms that support all phases of clinical trials. We partner with leading EDC providers and create customized Data solutions for our clients. We set up the study within 2-4 weeks and this includes eCRF design and all protocol required workflows.
We ensure that an appropriate EDC solution is matched with the clinical trial being conducted. Since different EDC solutions have their own attributes, not all of them can be used for every clinical trial. The requirements of a single-center Phase 1 in-patient study can be very different from a large multiple site out-patient Phase III study.
Clinexa utilizes industry-leading PV systems for delivering full range of PV solutions. We offer a broad range of expertise for supporting the safety oversight of marketed products including supporting safety oversight for clinical trials. Our PV team provides has expertise in preparing and reviewing pharmacovigilance documents. Other services that we provide include but are not limited to:
– Safety narratives
– Coding for AEs, SAEs, medications and medical history
– Causality and seriousness assessment
– Advisory services for pharmacovigilance
– PSURs & DSURs
Data Management (DM)
Clinexa offers customized Data Management solutions to our clients that best fit the needs of the clinical trial and the sponsor. Our processes are highly compliant to regulatory and international clinical trials guidelines and regulations but at the same time they are highly flexible so solutions can be individualized for each client. Our highly experienced Data Management team is continuously trained and upskilled to meet the continually changing requirements for managing clinical trial data. Following are the key services we offer:
– APAC in-region support for Data Management
– Dedicated Data Manager and support staff for each clinical trial
– Thorough Data Management Plan (DMP) and Data Validation Pan (DVP)
– Electronic Data Capture (EDC) and Electronic Case Report Form (eCRF)
– Database build and simulation
– Paper CRFs when needed
– ePRO solutions
– Medical Coding
– Edit checks and Data cleaning
– Blind review
– Database lock