Clinical Research and Clinical Data Management Training

Clinical research is the study that is administered by researchers on human subjects to understand drug interaction through clinical trials. It is a branch of medical science that is aimed at determining the efficacy and safety of drugs, medications, treatments, medical devices and aids, and diagnostic products. The science of clinical research is different from that of clinical practice. It largely involves the investigation of drugs and equipment that will be used to prevent a disease, treat it, diagnose it or control it. In clinical research, a research is required to interact directly with patients. Clinical practices employ established treatments while clinical research establishes a treatment. Investigations involved in clinical trials are carried out in conformation with formal protocols that determine exactly how the trials are to proceed. The trials are carried out in phases. The first phase involves the testing of a new drug, device or treatment in a small group of subjects to determine its safety, safe dosage range and side-effects. The next phase involves the administration of the drug to a larger number of subjects so that the treatment’s efficacy can be ascertained and its safety established. In the third phase, the treatment is administered to a large population of human subjects to confirm its efficacy, find out its side-effects, to compare it with other current treatment options, and to confirm its safety. Phase 4 is the stage in which studies are conducted after a treatment or drug is distributed across populations to find out its long-term effects and side effects.

Clinical data management is that aspect of clinical research that involves clinical data entry, validation, verification and quality control of data associated with clinical trials. It is a critical aspect of clinical research in which statistically relevant data is collected from clinical trials for research purposes. It relies on a large number of skill sets ranging from scientific, technical, to IT, engineering and even interpersonal skills. Clinical data management (CDM) involves various activities that include designing and creation of case report forms (CRF), annotations, data validation, data entry, data extraction and quality assurance. CDM involves the use of various data management tools, most of which are web-based. Those wishing for a career in CDM need to be able to conform to stringent regulations and protocols. Data management needs to be error-free in order to ensure the validity of the research findings.

Most training institutes offer integrated courses for clinical research and clinical data management, which may also include SAS training. The courses may range from a few weeks to several months. The classes may include both online and offline training. Most institutes offer flexible schedules in addition to one-on-one training along with course materials. The training may also include internship programs and on-the-job training. These courses have a great scope for those interested in the field and have the necessary background qualifications. However, in this field, as is the case in every other field, jobs can never be guaranteed. This is because while the courses are very much in demand and professionals in the field is also highly in demand, whether or not an individual can acquire a job depends on how far he has absorbed the training and has presented his skills in front of prospective employers. In order to ensure job guarantee, students should make sure they develop their personality, communication and interpersonal skills.

Courses taught by Clinical Data Management training institutes in Hyderabad cover various topics on the subject. A good course module should include case report form design, central laboratory data, clinical trial monitoring, clinical trial preparation, compliance and audits, computer system validation (CSV), data entry, data management and biostatistics, data management plan, data queries, data validation, database design and build, database finalization and extraction, epidemiology and evidence based medicine, essential documents and regulatory submission, ethics in clinical research, financial management of clinical trials, general introduction, medical device trials, metrics and tracking, other external data, patient recorded data, personality development and communication skills, pharmaceutical medicine, professional organizations for clinical data management, project and vendor management, quality control, regulatory affairs in clinical research, role of the clinical data manager in a clinical trial, roles and responsibilities, serious adverse event reconciliation, standard operating procedures, study start-up, therapeutic areas, user acceptance testing, and validation rules. While choosing an institute for Clinical Data Management training in Hyderabad, one must make sure the faculty is well experienced in the industry, rather just being an experienced trainer. No training institute can offer 100% placement guarantee but can offer 100% placement assistance. Placements depend solely on the skills exhibited by the job seeker. Additional skills that can be acquired by those seeking a job in the field include knowledge of Encoder Pro, typing test software, and Live Charts. There is no specific eligibility requirement for the course. However, it is advisable that those seeking this course should come from a life-science background. Most of the students who opt for this course are either graduates or post-graduates in life-science groups such as microbiology, biotechnology, genetics, etc. or are MBBS, BDS, BHMS, BAMS, nursing or pharmacy graduates or post-graduates. In order to pursue a fruitful career in the field, students should seek reputed institutes that offer Clinical Research and Data Management training in Hyderabad. Some institutes offer their own certifications while others offer certifications from other bodies. Irrespective of the course taken or the certification sought, students should strive to develop their soft-skills as well as their industry-based knowledge if they wish to further their careers or acquire employment easily. Among the various institutes for Clinical research and Data Management training in Hyderabad, Ikya Global Edu is one of the key leaders in the industry. The training institute offers 100% job assistance and has trainers from the industry. It also strives to make students job ready through an array of other courses and modules that develop the personality, soft-skills and interpersonal skills of students to get them better placed in the job market.