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BCRI provides you an innovative learning approach which allows you as a student to apply the theoretical knowledge and skills gained during the taught course in an effective manner in the clinical research industry.
Clinical Data Management is one of the Critical and important phases during all Clinical Research Trial Phases. Using specific Clinical Data Management techniques- Data collected during the clinical trial will be purified, cleaned, and statistically high-quality standards, data is prepared. Any drug/device development process needs such data management techniques to produce accurate and reliable life-saving molecules and medical equipment.
Clinical Data Management (CDM) is a process in Clinical Research, where it leads to the generation of high-quality, reliable, and statistically sound data from clinical trials.
The former one is currently mandated for use by the U.S. Food and Drug Administration (FDA), and the latter created a standard format for collecting data across studies so that data submissions can be more easily tracked and reviewed. Specialized tools are used in CDM to create audit trails that allow the discrepancies should be minimized even in large and complex clinical trials. Clinical data management systems (CDMS) are especially vital in clinical trials conducted across medical centers in which a huge amount of data is produced. Examples include Oracle Clinical, rave, eClinical suite, Clintrial, and Macro.
The Clinical Data Manager plays a key role in the setup and conduction of a clinical trial where the data collected during a clinical trial forms the basis of subsequent safety and efficacy—the analysis, which in turn leads to decision making on product development. The Clinical Data Manager is also involved in early discussions about data collection sources and then oversees the development of data collection tools based on the clinical trial protocol. The computer systems used in the processing and management of clinical trial output data must undergo validation to ensure that they perform as intended and that results are reproducible.
Clinical Data Management plays a crucial role in the data collection phase of Clinical Research, and it is the process of collecting and managing research data is done in accordance with regulatory standards to obtain quality information that is complete and free from error.
Clinical Data Management ensures the collection, integration, and availability of Clinical Data at appropriate quality, and it also supports conducting, manages, and analysis of studies across the spectrum of Clinical Research.
The field of clinical data management (CDM) has come about due to the requirement from both the pharmaceutical industry and the regulatory authorities for the development of pharmaceutical products to continue to accelerate, regulatory entities by requiring quality-assurance standards to be met in collecting the data used in the drug evaluation process. Such standards are created by the Clinical Data Interchange Standards Consortium (CDISC), are particularly vital to CDM, the Study Data Tabulation Model Implementation Guide for Human Clinical Trials (SDTMIG) and the Clinical Data Acquisition Standards Harmonization (CDASH).
Clinical Data Management (CDM) is a crucial component in clinical research, which leads to the generation of high-quality, clean, reliable, and statistically sound data from clinical trials which helps to produce drug development to marketing. Clinical data management (CDM) enables organizations to maintain data integrity throughout a clinical research study. Clinical data management ensures that a dataset is accurate, secure, reliable, and ready for analysis.
Clinical Data Management (CDM) relies on several essential tools to ensure the accuracy, integrity, and reliability of clinical trial data. EDC systems replace traditional paper-based data collection methods. They allow researchers to collect, manage, and monitor clinical trial data electronically. BCRI too will provide EDC access to students for their real-time scenarios.
The career path for a Clinical Data Manager typically begins with a bachelor’s degree in a relevant field such as life sciences, health sciences, or pharma. Entry-level positions may involve roles like Data Coordinator or Clinical Data Associate or Clinical Data Analyst. As the demand for well-managed and high-quality clinical trial data continues to grow, so does the need for skilled professionals is high in CDM.
The role of a Clinical Data Manager (CDM) is crucial in the field of clinical research, as they are responsible for overseeing the collection, management, and analysis of data generated during clinical trials. The primary focus of a Clinical Data Manager (CDM) is to ensure the accuracy, integrity, and quality of clinical trial data. CDMs contribute significantly to developing new medical treatments by ensuring reliable clinical trial data.
The Scope of Clinical Data Management includes wide range of activities: which includes Data Design and Collection: Crafting Case Report Forms (CRFs), development of protocols, defining data standards, and overseeing data capture from various sources like electronic systems, paper forms, and medical devices and this field has a broad scope of job opportunities across various sectors within the healthcare and pharmaceutical industries with roles like Clinical data manager (CDM), Clinical data coordinator, Data entry specialist, Clinical data analyst, Clinical Data Programmer, Quality Assurance Specialist (Clinical Data) etc..
Data Management in clinical research ensures data quality and compliance throughout the data life cycle, while SAS is a statistical analysis tool used after the data management phase for advanced analyses.
BCRI prepares students for the clinical research industry by providing a comprehensive curriculum, real-time exposure through practical projects, and potential industry collaborations. The institution focuses on developing advanced skills in clinical data management, pharmacovigilance, regulatory affairs, and Good Clinical Practice, fostering leadership capabilities for successful careers in the field.
Life science, Pharmacy, Medical Graduates & Post Graduates (including BDS, BAMS, BHMS, BPT)
CDM is majorly into the collection of Data and integration, while SAS is more about Data Analysis and final report generation. Choose based on your interest if more interested in enjoying working with data, managing clinical study databases, and being associated with data CDM is a fit, else you prefer statistical analysis, programming, analyzing data, create summary reports and SAS could be more appealing.
Yes, the internship will be provided at the end of the course for a period of two months. We believe that by performing an activity, internship enhance your existing theoretical knowledge and improves your skills.
Yes, We do have 100% placement Support on successful completion of the course. Each student is entitled to placement assistance. Our placement officer is dedicated to finding a suitable opportunity for each student. We are proud to state within a short duration we have been successful in placing our students in the field of clinical operations as CRCs and process coordinators, as drug safety associates in Pharmacovigilance departments, QA personnel in medical writing departments and as Jr. SAS programmers.
Students who have completed a course in clinical research from any other organization may approach us for internship assistance.
We cannot guarantee that a company will hire you, as it is based on your performance during an interview. However, we do provide 100% placement assistance. till date, we have 100% Placement record.
As Life Science Graduates, one can have good opportunities in Research & Development Wet & dry Labs, but not all get such opportunities. Enhancing your skills to work in a CRO will be the right choice. you can Join Courses Like PG Diploma in Clinical Research, Clinical Data Management, Pharmacovigilance, Medical Writing, Medical Coding, Clinical Data Analysis, etc,
Our Team would love to Guide you to select the right course here .
