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A clinical study report is a specialized document that contains every details incorporated in the clinical trial research. Clinical Study Reports should be documented with very special attention. Our highly qualified and experienced writers are adept at writing clinical reports with precision.
We work to ensure accurate data presentation and interpretation, strict adherence to regulatory guidelines, and sponsor requirements. Our group of strong medical writers and research scientists will quickly analyse data and present it in a meaningful way, ensuring a high quality study report.
Covalent offers complete Clinical Data Management Services to meet your data processing, analysis and management needs. Our team of experts can assist you by providing high-quality, comprehensive services that meet your specific requirements. From case report form design to the completion of the final study report, Covalent's Clinical Data Management Services fully compliment your organization's resources.
Because we specialize in the pharmaceutical industry, Covalent can effectively perform these services with minimal start-up time. Our first-hand experience with FDA regulatory requirements and typical in-house data management and quality assurance procedures help to assure that we can complete your project on time and within budget. Managed and staffed by experts in the pharmaceutical industry, our data management group has relevant experience in clinical data entry and management, as well as case report form and clinical database design, dictionary coding, and statistical analysis and reporting. In addition, our staff is familiar with most of the computer hardware, operating systems, and applications software that are utilized in this industry. Covalent also has the technical resources to develop customized clinical data management and analysis solutions by interfacing SAS® software with different programming languages and database management systems. Think of Covalent as an extension of your clinical data management organization. Our experienced personnel are available to supplement your resources during peak workload periods.
Skilled data entry personnel perform data entry, independent double-entry verification, and review. We utilize a double-key verification system that complies with industry standards for data and system quality and integrity. In addition, all entered data are reviewed by trained Data Management personnel to ensure database accuracy and consistency. Missing or inconsistent data are identified and submitted for reconciliation. The resulting database can be provided to you as a SAS® dataset or a number of standard database formats that are compatible with your current system.
Our clinical data entry and management personnel have numerous years of experience using accepted industry-standard dictionaries, including WHO Adverse Events and Concomitant Medications, COSTART, ICD-9 and MedDRA. Your data can be coded to these dictionaries or coded using a sponsor-supplied dictionary.
Databases are designed according to format specifications and naming conventions provided by the sponsor. In the absence of sponsor guidelines, we will use our internally established standards and procedures. These standards conform to the CDISC standards. Whichever method is chosen, you will be provided with a complete, validated database which can be integrated with existing databases and provide the basis for the subsequent reporting and analysis of results.
Listings and summaries are generated using either specifications provided by the sponsor, or our own standards, which are based on U.S. or ICH guidelines. All programs are internally validated and can be provided to you in a form that best supports subsequent statistical analysis, reporting or inclusion in an electronic submission.
Working with client's staff, Covalent can provide protocol planning and development services, statistical analysis plan preparation and review, study analysis, generation of a statistical or integrated clinical study report, and regulatory submission planning. For growing biopharmaceutical companies that may not have a clinical research department with all services in operation, Covalent can provide periodic on-site and virtual support in statistics and data operations.
Case report forms (CRFs) are designed to accurately and consistently capture the data that are defined by a protocol, making it easy to review and analyze those data. We can use our standard CRF modules as templates, or you can provide examples of your own CRFs. In either case, we will provide you with CRFs that comply with your format standards and regulatory compliance requirements.
Our personnel have direct experience monitoring clinical trials and processing adverse event data for both ICH and FDA submissions. We will monitor your trial according to "Good Clinical Practices" (GCP) guidelines that have been established by the FDA and the ICH. We will work closely with your drug safety and regulatory personnel to assure the accurate and timely submission of critical safety data.
The development and utilization of SOPs within Clinical Data Management promote quality, improve personnel productivity, and help to assure compliance with regulatory requirements. We have produced a complete series of Clinical Data Management SOPs for our internal use as well as for our clients. We can provide you with general SOPs that you can customize, or we can customize them for you after we have determined your unique requirements.
Our experienced clinical auditors and data management staff can provide GCP and 21 CFR part 11 compliance audits of clinical trials and the software used for processing clinical trials. Covalent provides a range of services from executive summaries to in-depth analyses of data management processes and data integrity assessments with findings and recommendations for remediation.
Covalent applies its expertise in a practical and logical way to help companies worldwide. We continually strive for innovation and we share our principles and practices through training, presenting, and publishing. We develop services and creative offerings that provide new and more efficient ways for our customers and their vendors, suppliers, and service providers to conduct their business both within regulatory compliance and with reduced risk. We are prepared to achieve the same results for you.