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Clinical Data Management & Biometrics, Software, Clinical Databases, Database Programming, e-Clinical Technology Solutions, Electronic Data Capture (EDC), Clinical Development Document Management, Electronic Laboratory Notebook System, Rapid Data Delivery, Electronic Investigative Site Files (eISF), Electronic Data Transfer (EDT), Medical Coding (MedDRA, WHODrug), Database Design, eCRF Design & System Configuration, Phase I EDC Solution, data quality Source data are generated. Common examples of source data are clinical site medical records, laboratory results, and patient diaries. If paper Case Report Forms (CRFs) are being used, the clinical site records are transcribed onto the CRFs. Data from the CRFs, as well as other source data, are entered into the clinical trial database. Electronic CRFs (eCRFs) allow data to be entered directly into the database from source documents. Data from paper CRFs are often entered twice and and reconciled in order to reduce the error rate. The data are checked for accuracy, quality, and completeness, and problems are resolved. This often involves queries to the clinical site. The database is locked when the data are considered final. The data are reformatted for reporting and analysis. Tables, listings, and figures are generated. The data are analyzed, and the analysis results are reported. When significant results are found, this step may result in the generation of additional tables, listings, or figures. The results are integrated into high-level documentation such as Investigator’s Brochures (IBs) and Clinical Study Reports (CSRs). The database and other study data are archived. The source of the data is known and attributable. The data are legible: readable and comprehensible to humans. The data are recorded when they are generated i.e. should be contemporaneous, the original data are the first recording from the primary source. Accurate data are correct.Practically, quality data also requires at least three other aspects i.e. data are readily available, transmissible, and storable; data are complete and unbiased; data are in a format that is internally consistent and compliant with or readily transformable to accepted standards. 21 CFR 11 details the predicate rules that are required to insure that electronic records are “trustworthy [and] reliable”. Proper implementation of 21 CFR 11 helps ensure that the Attributable, Legible, Original, and Accurate aspects of the ALCOA standard are met. Validation of clinical data management programs and procedures is required to document that clinical data management standards are met. Clinical trial data management service providers provide end to end comprehensive clinical data management solutions from Phase I through to post-marketing trials. Team of global clinical data management experts are committed to upholding a standardized, process-driven approach. Various clinical data management services comprise on-shore and off-shore Clinical Data Management Services, EDC and Paper Trial Set-Up & Management, Certified Medidata RAVE Builders, Access to other EDC solutions (Low Cost, Oracle etc.), Data Management Plan (DMP) development, Data Management Project Management, CRF/eCRF design and development, CRF Annotation & Review, Database Build & Design, Data validation specifications, Edit checks Programming & Testing, Data processing through double data entry, Query Management, Medical Coding, Safety Data Management & Reconciliation, Data Export/Transfer, CDASH Compliant deliverables, Real-time data viewing and reporting. Clinical data management is a relevant and important part of a clinical trial. All researchers try their hands on CDM activities during their research work, knowingly or unknowingly. Without identifying the technical phases, we undertake some of the processes involved in CDM during our research work. This article highlights the processes involved in CDM and gives the reader an overview of how data is managed in clinical trials. CDM is the process of collection, cleaning, and management of subject data in compliance with regulatory standards. The primary objective of CDM processes is to provide high-quality data by keeping the number of errors and missing data as low as possible and gather maximum data for analysis. To meet this objective, best practices are adopted to ensure that data are complete, reliable, and processed correctly. This has been facilitated by the use of software applications that maintain an audit trail and provide easy identification and resolution of data discrepancies. Sophisticated innovations have enabled CDM to handle large trials and ensure the data quality even in complex trials. High-quality data should be absolutely accurate and suitable for statistical analysis. These should meet the protocol-specified parameters and comply with the protocol requirements. This implies that in case of a deviation, not meeting the protocol-specifications, we may think of excluding the patient from the final database. It should be borne in mind that in some situations, regulatory authorities may be interested in looking at such data. Similarly, missing data is also a matter of concern for clinical researchers. High-quality data should have minimal or no misses. But most importantly, high-quality data should possess only an arbitrarily ‘acceptable level of variation’ that would not affect the conclusion of the study on statistical analysis. The data should also meet the applicable regulatory requirements specified for data quality. Many software tools are available for data management, and these are called Clinical Data Management Systems (CDMS). In multicentric trials, a CDMS has become essential to handle the huge amount of data. Most of the CDMS used in pharmaceutical companies are commercial, but a few open source tools are available as well. Commonly used CDM tools are ORACLE CLINICAL, CLINTRIAL, MACRO, RAVE, and eClinical Suite. In terms of functionality, these software tools are more or less similar and there is no significant advantage of one system over the other. These software tools are expensive and need sophisticated Information Technology infrastructure to function. Additionally, some multinational pharmaceutical giants use custom-made CDMS tools to suit their operational needs and procedures. Among the open source tools, the most prominent ones are OpenClinica, openCDMS, TrialDB, and PhOSCo. These CDM software are available free of cost and are as good as their commercial counterparts in terms of functionality. These open source software can be downloaded from their respective websites.

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Data Management & Database Programming

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We perform Data Management & Database Programming including Study database set-up and maintenance Data Management Plan, data cleaning, coding, query issue and database lock.

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Solid Organ Transplant Solutions

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The OTTR CompleteOrgan solution simplifies data collection, patient tracking and data management. Our software includes liver, kidney, pancreas, heart, lung, intestine and islet cell transplant solutions.

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ClinPlus® Data Management

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ClinPlus Data Management (CPDM) software, our classic data management system designed to support paper-based studies, has helped clients manage clinical studies across multiple therapeutic areas and collect quality data while meeting strict timelines and budget constraints.

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Clinical Trial Management System (CTMS) Softw...

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A Clinical Trial Management System (CTMS) is a software solution targeted for the Life Science industry. CTMS is commonly used to manage processes and large amounts of data involved with clinical trial management and clinical study management.

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Rapid Data Delivery

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You need your data rapidly to make crucial dosing decisions during a study. At Quotient, data are available in the study database within hours of collection, ready for remote sponsor access.

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Hematopoietic Cellular Therapy Solutions

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With the growth of next-generation therapies, you’ll need a software solution that keeps pace with evolving regulatory requirements. Our cellular therapy software includes workflow support for all hematopoietic cellular therapy products.

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Data Management

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At LabConnect, we’ve combined these processes with a state-of-the-art data management platform ensuring delivery of clean data according to your exact specifications. Upon study award, we will establish your global data and information management plan.

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Clinical Data Management Software LSR Trials

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LSR Trials’ custom database software is used at all sites to manage information flow.

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Planning & Project Management

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Initially, our feasibility team develops the Synexus Delivery Plan. This provides an accurate assessment of how we plan to deliver the study with full protocol compliance, based on a medically evaluation of the protocol and any potential obstacles.

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Phase I EDC Solution

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Spaulding Clinical offers a fully integrated, paperless Phase I EDC solution that redefines efficiency.

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Data Management & Biometrics

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Data Management and Biometrics at Celerion bridges the gap between medical practice and laboratory science by assessing the safety of drug products to maximize drug effects and minimize side effects.

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eCRF Design & System Configuration

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Spaulding Clinical Research is revolutionizing the way clinical trial information is collected, analyzed, distributed, accessed, reviewed and managed - saving time and ensuring high quality study data.

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Sub Category: Data Management

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Data Management & eClinical Solutions

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For each project, we develop a data management plan (DMP) that identifies the study-specific quality control steps that we will take to review the data for accuracy and completeness.

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Pharma Service: Clinical Trials

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Sub Category: Data Management

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E-Clinical Technology Solutions

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TransPerfect is proud to offer Trial Interactive, our 21 CFR Part 11 compliant, web-based e-clinical solution

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Data Analytics

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The accurate collection, measurement and analysis of clinical data requires expertly trained data and clinical professionals, coupled with an industry-leading eClinical platform.

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Clinical Development Document Management

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Trial Interactive is the all-inclusive source for all of your clinical data management needs. In addition to hosting clinical trial solutions and electronic case site solutions, we also provide a full array of scanning and clinical document management services.

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Data Management Plan

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Spaulding Clinical Research is revolutionizing the way clinical trial information is collected, analyzed, distributed, accessed, reviewed and managed - saving time and ensuring high quality study data.

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Pharma Service: Clinical Trials

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Sub Category: Data Management

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Electronic Data Capture & Electronic Case Rep...

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More and more clinical trials are moving toward electronic data capture (EDC) for source documents and CRFs, particularly for pharmaceutical trials. RCTS has worked with EDC systems of several pharmaceutical companies.

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Clinical Data Management

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Whether you need expert advice on pivotal Phase III submission studies or a data management team for the entire program, our solutions custom-fit the scope, budget and timeline.

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Database Design 

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Spaulding Clinical Research is revolutionizing the way clinical trial information is collected, analyzed, distributed, accessed, reviewed and managed - saving time and ensuring high quality study data.

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Medical Coding (MedDRA, WHODrug)

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Spaulding Clinical Research is revolutionizing the way clinical trial information is collected, analyzed, distributed, accessed, reviewed and managed - saving time and ensuring high quality study data.

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ePROVIDE Clinical Database

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The ePROVIDE™ platform combines the data of the three databases. Therefore it enables users to search and cross-check all information available.

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Breaking the Data Barrier

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At PAREXEL®, we believe the world would be a better place if life-changing therapies could get to market more easily. But meeting the challenges of today’s drug development environment takes advanced, integrated technology and expert services that help break the barriers created by clinical

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Electronic Data Transfer (EDT)

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Spaulding Clinical Research is revolutionizing the way clinical trial information is collected, analyzed, distributed, accessed, reviewed and managed - saving time and ensuring high quality study data.

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Electronic Investigative Site Files (eISF)

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The Trial Interactive eISF offers a complete solution for electronic distribution, collection and management of essential investigator site files.

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CDISC Compliant Format (Study Data Tabulation...

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Spaulding Clinical Research is revolutionizing the way clinical trial information is collected, analyzed, distributed, accessed, reviewed and managed - saving time and ensuring high quality study data.

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Electronic Data Capture (EDC)

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PPD has significant experience in database building, clinical monitoring and data management activities using multiple EDC systems, including Medidata Rave, Oracle® Clinical Remote Data Capture, InForm and OmniComm®.

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Electronic Regulatory & Study Binders

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Trial Interactive includes workflow to promptly facilitate the review and approval by the trial sponsor and then provides an organized, searchable electronic Regulatory Binder as well as Study Binders if required by the sponsor or institution.

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Pharma Service: Clinical Trials

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Electronic Trial Master Files (eTMF)

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Trial Interactive provides companies with the ability to set up eTMFs in a matter of hours and can even be organized based on the file structure which is currently in place, allowing access to internal users as well as any partners with high level security access.

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Pharma Service: Clinical Trials

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Endpoint Adjudication

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Trial Interactive provides a collaborative work space for all relevant stakeholders – including investigative site personnel, core labs, and study teams – where these cases can be collected and delivered to adjudicators.

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Pharma Service: Clinical Trials

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Sub Category: Data Management

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Data Management

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Our data-managers are part of the team to make a medical device study a success. They actively participate in the design and implementation of a trial, using their vast experience and specific medical device knowledge to serve the goal of the study.

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Pharma Service: Clinical Trials

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Sub Category: Data Management

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Clinical Data Management Services

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PPD’s clients can employ the technology, processes and expertise that best meet the needs of their project with PPD’s clinical data management solutions. Across a broad range of therapeutic areas and quantitative methods, PPD has extensive data management experience for Phase I-IV clinical

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Pharma Service: Clinical Trials

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Sub Category: Data Management

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Full Service Data Management Support

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The Clinical Data Management unit efficiently manages all aspects of data handling in accordance with the protocol, the data management plan, efficient data capture, accurate data and timely completion of the clinical database.

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Pharma Service: Clinical Trials

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Sub Category: Data Management

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Electronic Laboratory Notebook System

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Electronic laboratory notebook enables faster access to data and improved information quality due to centralized data repositories.

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Pharma Service: Clinical Trials

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Sub Category: Data Management

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Clinical Data Management, Technologies & Prog...

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Chiltern’s industry-leading team of data management professionals and statisticians is one of the largest in the industry. With real-world experience in adaptive trial designs and the latest data analytics platforms and technologies, we make certain you can not only access, but also examine

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Pharma Service: Clinical Trials

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Sub Category: Data Management

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Data Management Documentation (DMP, DVP, DMR,...

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The Clinical Data Management unit efficiently manages all aspects of data handling in accordance with the protocol, the data management plan, efficient data capture, accurate data and timely completion of the clinical database.

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Pharma Service: Clinical Trials

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Sub Category: Data Management

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Electronic Data Capture

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The DataLabs® EDC (Electronic Data Capture) solution is uniquely focused on simplifying workflows and delivering superior user experiences. Its advanced EDC features help streamline the entire process starting from study design all the way to collection, management and reporting of clinical

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Pharma Service: Clinical Trials

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Sub Category: Data Management

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Clinical Data Management Services

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We provide complete data management services from protocol design to database Lock, aiming at delivering the services in compliance with the regulatory requirements, standard operating procedures, & client specific requirements if any.

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Pharma Service: Clinical Trials

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Sub Category: Data Management

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Clinical Data Management

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Our systems, SOPs, project personnel are equipped to provide secure Clinical Data Management services to support to Phase II-IV clinical trials & enabling EDC & eCRF. Our services include Database Design & Validation, CRF, Clinical Data review etc.

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Pharma Service: Clinical Trials

Category: Technology / Data / Analytics

Sub Category: Data Management

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Clinical Data Services

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Navitas partners with you to deliver full clinical data services across Clinical Data Management, Biostatistics & Statistical programming, Clinical Data Standardization, and Medical Writing.

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Pharma Service: Clinical Trials

Category: Technology / Data / Analytics

Sub Category: Data Management

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Clinical Data Management

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We offer comprehensive Clinical Data Management services including Data management plan, Data capture, database designing, Independent double data entry verification, Complete data validation, generation of data validation report & Quality Assurance

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Pharma Service: Clinical Trials

Category: Technology / Data / Analytics

Sub Category: Data Management

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Data Management - Electronic Data Capture

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We assign International Project Manager who ensures a sponsor’s contact point for all trial-related questions.

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Pharma Service: Clinical Trials

Category: Technology / Data / Analytics

Sub Category: Data Management

Clinical Data Management & Biometrics, Software, Clinical Databases, Database Programming, e-Clinical Technology Solutions, Electronic Data Capture (EDC), Clinical Development Document Management, Electronic Laboratory Notebook System, Rapid Data Delivery, Electronic Investigative Site Files (eISF), Electronic Data Transfer (EDT), Medical Coding (MedDRA, WHODrug), Database Design, eCRF Design & System Configuration, Phase I EDC Solution, data quality Source data are generated. Common examples of source data are clinical site medical records, laboratory results, and patient diaries. If paper Case Report Forms (CRFs) are being used, the clinical site records are transcribed onto the CRFs. Data from the CRFs, as well as other source data, are entered into the clinical trial database. Electronic CRFs (eCRFs) allow data to be entered directly into the database from source documents. Data from paper CRFs are often entered twice and and reconciled in order to reduce the error rate. The data are checked for accuracy, quality, and completeness, and problems are resolved. This often involves queries to the clinical site. The database is locked when the data are considered final. The data are reformatted for reporting and analysis. Tables, listings, and figures are generated. The data are analyzed, and the analysis results are reported. When significant results are found, this step may result in the generation of additional tables, listings, or figures. The results are integrated into high-level documentation such as Investigator’s Brochures (IBs) and Clinical Study Reports (CSRs). The database and other study data are archived. The source of the data is known and attributable. The data are legible: readable and comprehensible to humans. The data are recorded when they are generated i.e. should be contemporaneous, the original data are the first recording from the primary source. Accurate data are correct.Practically, quality data also requires at least three other aspects i.e. data are readily available, transmissible, and storable; data are complete and unbiased; data are in a format that is internally consistent and compliant with or readily transformable to accepted standards. 21 CFR 11 details the predicate rules that are required to insure that electronic records are “trustworthy [and] reliable”. Proper implementation of 21 CFR 11 helps ensure that the Attributable, Legible, Original, and Accurate aspects of the ALCOA standard are met. Validation of clinical data management programs and procedures is required to document that clinical data management standards are met. Clinical trial data management service providers provide end to end comprehensive clinical data management solutions from Phase I through to post-marketing trials. Team of global clinical data management experts are committed to upholding a standardized, process-driven approach. Various clinical data management services comprise on-shore and off-shore Clinical Data Management Services, EDC and Paper Trial Set-Up & Management, Certified Medidata RAVE Builders, Access to other EDC solutions (Low Cost, Oracle etc.), Data Management Plan (DMP) development, Data Management Project Management, CRF/eCRF design and development, CRF Annotation & Review, Database Build & Design, Data validation specifications, Edit checks Programming & Testing, Data processing through double data entry, Query Management, Medical Coding, Safety Data Management & Reconciliation, Data Export/Transfer, CDASH Compliant deliverables, Real-time data viewing and reporting. Clinical data management is a relevant and important part of a clinical trial. All researchers try their hands on CDM activities during their research work, knowingly or unknowingly. Without identifying the technical phases, we undertake some of the processes involved in CDM during our research work. This article highlights the processes involved in CDM and gives the reader an overview of how data is managed in clinical trials. CDM is the process of collection, cleaning, and management of subject data in compliance with regulatory standards. The primary objective of CDM processes is to provide high-quality data by keeping the number of errors and missing data as low as possible and gather maximum data for analysis. To meet this objective, best practices are adopted to ensure that data are complete, reliable, and processed correctly. This has been facilitated by the use of software applications that maintain an audit trail and provide easy identification and resolution of data discrepancies. Sophisticated innovations have enabled CDM to handle large trials and ensure the data quality even in complex trials. High-quality data should be absolutely accurate and suitable for statistical analysis. These should meet the protocol-specified parameters and comply with the protocol requirements. This implies that in case of a deviation, not meeting the protocol-specifications, we may think of excluding the patient from the final database. It should be borne in mind that in some situations, regulatory authorities may be interested in looking at such data. Similarly, missing data is also a matter of concern for clinical researchers. High-quality data should have minimal or no misses. But most importantly, high-quality data should possess only an arbitrarily ‘acceptable level of variation’ that would not affect the conclusion of the study on statistical analysis. The data should also meet the applicable regulatory requirements specified for data quality. Many software tools are available for data management, and these are called Clinical Data Management Systems (CDMS). In multicentric trials, a CDMS has become essential to handle the huge amount of data. Most of the CDMS used in pharmaceutical companies are commercial, but a few open source tools are available as well. Commonly used CDM tools are ORACLE CLINICAL, CLINTRIAL, MACRO, RAVE, and eClinical Suite. In terms of functionality, these software tools are more or less similar and there is no significant advantage of one system over the other. These software tools are expensive and need sophisticated Information Technology infrastructure to function. Additionally, some multinational pharmaceutical giants use custom-made CDMS tools to suit their operational needs and procedures. Among the open source tools, the most prominent ones are OpenClinica, openCDMS, TrialDB, and PhOSCo. These CDM software are available free of cost and are as good as their commercial counterparts in terms of functionality. These open source software can be downloaded from their respective websites.

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