ClinVigilant'EDC In Clinical Trials

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An integrated eclinical platform for fast and easy study setup and smart clinical data management for all phases of clinical trials. ClinVigilant’s EDC is a highly configurable platform to create the eCRF from paper CRF or directly using our eCFR tool. Key Features: •CDASH / SDTM based library • Real Time Data Validation & Edit / Checks • Subject Management & Training Management • Study level Workflow Management • Visit Scheduling, Medical Coding • Manage Central and Local Labs Clinvigilant is one of the Best Electronic Data Capture(EDC), Electronic Trial Master File(eTMF) and Patient Engagement Solutions Systems Providers in Clinical Trials. If you want more information kindly connect with bd@clinvigilant.com

Healthcare

What is EDC?
An integrated eclinical platform for fast and easy study setup
and smart clinical data management for all phases of clinical
trials.
ClinVigilant’s EDC is a highly configurable platform to create
the eCRF from paper CRF or directly using our eCFR tool.

ClinVigilant’s EDC Highlights
1) Manage Phase I-IV Studies
2) Design eCRF with Multilingual
3) CDASH - CDISC based Global Library
4) Medical Coding Tool
5) Set Dynamic Workflow and Patient Scheduling
6) Regulatory Complaint

Features of ClinVigilant’s EDC
CDASH/SDTM based library
- Real Time Data Validation & Edit / Checks
- Subject Management & Training Management
- Study Level WOrkflow Management
- Visit Scheduling, Medical Coding
- Manage Central and Local Labs

Contact Us On bd@clinvigilant.com for more information on EDC
or visit our website clinvigilant.com/electronic-data-capture/

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The Covid-19 pandemic has created new obstacles to overcome. At Raptim, we overcome these obstacles by adopting innovative techniques involving the use of advanced technology that enables us to manage clinical trials and studies more efficiently. We implement electronic tools that help us improve our outcomes in various domains. Regular training ensures that our team stays up-to-date with research, regulatory affairs and clinical trials in the industry. In addition to that, our team also undergoes training to work with various ERP software and management systems that are employed in the industry.

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T R I A L M O N I T O R I N G Quality Remote Monitoring: The Tools of the Game Penelope Manasco, MD Outlining those technologies best able to raise the data and process quality of risk-based monitoring. A critical aspect of risk-based monitoring (RBM) is rapid access to a site’s clinical data. In 2013, industry median values from 2009-2012 Phase II and III clinical trials (see Figure 1 on facing page) showed that the median time from electronic case report (eCRF) entry to data manager query opened was 59 to 89 days. This is even more extraordinary when one considers that the median time from subject visit to query close (all queries including automatically generated queries) ranged from 30 to 36 days.' These findings emphasize that direct data en try, either into the electronic data capture (EDC) or eSource systems, provides significant value in overseeing study conduct quality. Mitchel et al.2 reported on their experience implementing direct data entry (DDE) and RBM in a clinical trial of 18 investigative sites in the U.S. and Canada study ing 180 research subjects. In that trial, 92% of the data was entered within one day of the subject visit and 98% within eight days. Data review was also faster with 50% of the data reviewed within 13 hours of data entry. Source data verification (SDV) was completed at the site for approximately 20% of the data within the EDC. There were changes on 0.8% of the pages, with the majority in three areas: concomitant medications, medical history, and clinical laboratory results. The evidence above, coupled with the find ing that SDV was not an adequate approach to ensure trial quality,5 illustrates the importance of technology and process changes that should be implemented to enhance remote trial oversight as envisioned by the FDA,2 European Medicines Agency (EMA),5 and International Conference on Harmonization (1CH) guidance6 documents on RBM and quality management. The following tech nology solutions can provide significant benefits to implementing RBM and remote trial manage ment. Technology solutions EDC and eSource Direct data entry can be accomplished though web-based EDC solutions and tablets, it is imper ative that sites have adequate Internet access to use tablets for direct data entry. Sites benefit from eliminating transcription of documents. Moni tors and data managers also benefit from having immediate access to the data. Questions that document good clinical practice (GCP) compli ance can be incorporated into the EDC or eSource. These fields (e.g„ detailing timing for vital signs, informed consent processes) enable monitors to conduct source data review remotely. Many data managers may not be familiar with the additional questions the monitor will want to have docu mented, so cross-functional input into the EDC is needed during design. Tablet setup and testing ensures tablets work as needed by the site. The initiation visit should i ...

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Electronic Data Capture (EDC) systems are software applications designed to streamline the process of data collection and management in clinical trials and other research studies. EDC systems replace traditional paper-based data collection methods, allowing for more efficient and accurate data capture. Here are some key aspects of EDC systems and how they streamline data collection and management: Data Entry and Validation: EDC systems provide a digital platform for data entry, eliminating the need for paper forms. Researchers can enter data directly into electronic case report forms (eCRFs) using user-friendly interfaces. EDC systems often include built-in data validation checks, reducing data entry errors and ensuring data accuracy. Real-Time Data Capture: EDC systems enable real-time data capture, allowing researchers to enter data as it is collected during study visits or remotely. This reduces the time lag between data collection and data availability for analysis. Real-time data capture facilitates timely decision-making, data monitoring, and data quality control. Electronic Source Data Verification (eSDV): EDC systems support electronic source data verification, where the electronic data captured in the system can be compared with the original source documents, such as electronic health records or laboratory reports. This simplifies the process of data verification, ensuring data accuracy and reliability. Data Management: EDC systems streamline data management processes by automating tasks such as data cleaning, query management, and data reconciliation. They provide functionalities to track and resolve data queries, allowing efficient communication between investigators and data management teams. EDC systems also facilitate data exports and transfers to statistical analysis software. Remote Data Capture: EDC systems support remote data capture, enabling participants to enter data from their own locations using secure online portals. This eliminates the need for participants to travel to study sites for data entry, reducing participant burden and improving data collection efficiency. Data Security and Compliance: EDC systems employ robust security measures to protect data confidentiality and integrity. They adhere to regulatory requirements, such as the Health Insurance Portability and Accountability Act (HIPAA) in the United States and the General Data Protection Regulation (GDPR) in the European Union, ensuring compliance with data privacy and security standards. Data Monitoring and Auditing: EDC systems provide tools for data monitoring and auditing. They enable remote monitoring of data quality, allowing sponsors or monitors to review data in real-time, identify discrepancies or errors, and take necessary actions promptly. EDC systems also facilitate centralized data monitoring and remote audits, minimizing on-site visits and associated costs.

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Catheterization of the bladder involves introducing a latex or plastic tube through the urethra and into the bladder. The catheter provides a continuous flow of urine in patients unable to control micturition or those with obstructions. It also provides a means of assessing urine output in hemodynamically unstable patients. Because bladder catheterization carries the risk of UTI, blockage, and trauma to the urethra, it is preferable to rely on other measures for either specimen collection or management of incontinence. Types of Catheterization. Intermittent and indwelling retention catheterizations are the two forms of catheter insertion INTERMITTENT CATHETERIZATION introduce a straight single-use catheter long enough to drain the bladder (5 to 10 minutes When the bladder is empty, you immediately withdraw the catheter. COMPLICATION- increases risk of trauma and infection. INDICATION- It is common for people with spinal cord injury or other neurological problems such as multiple sclerosis to perform self– intermittent catheterization up to every 4 hours daily for months or years. UTI rate is lower than for patients with long-term indwelling catheters. INDWELLING CATHETERIZATION- remains in place for a longer period, until a patient is able to void voluntarily or continuous accurate urine measurements are no longer needed The straight single-use catheter has a single lumen with a small opening about 1.3 cm ( 1 2 inch) from the tip. . Urine drains from the tip, through the lumen, and to a receptacle. An indwelling Foley catheter has a small inflatable balloon that encircles the catheter just above the tip. When inflated the balloon rests against the bladder outlet to anchor the catheter in place. The indwelling retention catheter often has two or three lumens within the body of the catheter . One lumen drains urine through the catheter to a collecting tube. A second lumen carries sterile water to and from the balloon when it is inflated or deflated. A third (optional) lumen is sometimes used to instill fluids or medications into the bladder. It is easy to determine the number of lumens by the number of drainage and injection ports at the end of the catheter A second type of intermittent catheter has a curved tip A Coudé catheter is used on male patients who may have enlarged prostates that partly obstruct the urethra. It is less traumatic during insertion because it is stiffer and easier to control than the straight-tip catheter Plastic catheters are suitable only for intermittent use because of their inflexibility Latex catheters are recommended for use up to 3 weeks. Be aware of allergies. Pure silicon or Teflon catheters are best suited for long-term use (2 to 3 months) because of less encrustation at the urethral meatus Balloon sizes range from 3 mL (pediatric) to large postoperative volumes (75 mL). In adults the 5-mL and 30-mL sizes are the most common: The 5-mL size allows for optimal drainage, whereas the 30-mL size is used after pros

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ClinVigilant'EDC In Clinical Trials

1. ClinVigilant EDC

2. What is EDC? An integrated eclinical platform for fast and easy study setup and smart clinical data management for all phases of clinical trials. ClinVigilant’s EDC is a highly configurable platform to create the eCRF from paper CRF or directly using our eCFR tool.

3. ClinVigilant’s EDC Highlights 1) Manage Phase I-IV Studies 2) Design eCRF with Multilingual 3) CDASH - CDISC based Global Library 4) Medical Coding Tool 5) Set Dynamic Workflow and Patient Scheduling 6) Regulatory Complaint

4. Features of ClinVigilant’s EDC CDASH/SDTM based library - Real Time Data Validation & Edit / Checks - Subject Management & Training Management - Study Level WOrkflow Management - Visit Scheduling, Medical Coding - Manage Central and Local Labs

5. Contact Us On bd@clinvigilant.com for more information on EDC or visit our website clinvigilant.com/electronic-data-capture/

ClinVigilant'EDC In Clinical Trials

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