When clinical trials are conducted, a huge amount of data gets generated. But how is this data collected and managed?
A team of clinical data managers, researchers, clinical research associates, clinical research coordinators, and many other professionals collectively manages clinical data. In other words, Clinical Data Management (CDM) is a procedure of collecting, generating and integrating statistically correct data from clinical trials. It is noteworthy that CDM only aims at gathering error-free data and abides by local, state, and federal regulations. Clinical Data Management has a significant role in drug development as well.
CDM – A multifaceted process
The CDM process involves several steps like Case Report Form (CRF), database designing, data validation, data entry, CRF annotation, data extraction, medical validation, and even database locking. The data processed must be cross-checked thoroughly to ensure the highest level of accuracy. Efforts are put towards accumulating maximum data for analysis.
Off late, upgraded software applications have enabled data analysis possible even in complex trials. In any case, there should be no lag between numbers or discrepancies across data gathered. It should always be kept in mind that regulatory bodies might ask to present specific data in some cases. In such conditions, no data should be missing and must be revealed exactly in the manner it is asked for. The data should have bare minimum deviations so that it does not budge the inferences of the findings. A faulty bunch of data might end up being a matter of concern for clinical researchers. The data analysis methods must match the protocol-specified parameters as laid down.
What can get you into the Clinical Data Management field?
Since data management and integration is quite a crucial stage in clinical research, the people doing it should be well-versed and qualified for the process. Thus, there are courses wherein CDM professionals are imparted training to understand the data management process, various data management tools and improve data quality.
With clinical trial methods reaching new heights with technology advancement, there happens to be massive scope for students in this field.
So, what can a CDM aspirant expect from a Clinical Data Management course?
- Learn the importance of data in clinical trials
- Various aspects of managing data effectively
What are the courses that you can pursue?
Lifepoint Research Centre in Wakad, Pune, offers the best in class training methodology with an energetic learning environment enhancing your skills in the clinical research area.
Courses that Lifepoint Research Centre offers are:
- Advance Post Graduate Diploma in Clinical Research
- Clinical Data Management and Pharmacovigilance
Eligibility criteria
- MBBS
- BDS
- BAMS, BHMS
- B.PHARM, M. PHARM
- B.Sc, M.Sc, B.Tech (LIFE-SCIENCES, BIOTECH, NURSING)
As Clinical Data Management is substantially a specialized field, potential candidates must have a certain set of skills in addition to the above list of criteria. Analyzing and drawing conclusions from the available datasheet needs absolute precision and meticulousness.
Thus, it creates an edge for CDM aspirants if they possess the below skills as well:
- Good understanding of drug development process
- In and out knowledge of ICH-GCP guidelines
- Should have an idea about drug regulatory authorities like EMEA, US FDA, DCGI
- Firm knowledge about computer and IT
- Skills to save, store or record data well
- Out-of-box thinking
- Leadership skills
- Good at both – An individual contributor and a team player
Jobs that you may bag after completing a Clinical Data Management course:
- Clinical data manager
- Bio-statistician
- Clinical data entry operator
- Clinical data reviewer
- Clinical coder
- Clinical research manager
- Data analyst
- Research assistant
What does Lifepoint Research Centre offer under a CDM course?
- Clinical Research and Guidelines – Introduction
- Process flow of CDM
- Data entry and Reconciliation
- Clinical Trial Design
- Project Management and QC Compliance
- PV Regulatory guidelines
- TMF and GDP
- Personality Development
Why should you certify in a CDM course at Lifepoint Research Centre?
- Each batch contains a limited number of students to increase attention per student.
- Around 15 faculties holding industry experience
- 2 weeks of hands-on training at clinical research individually for each student.
- Training through on-site assignments and assessments
- Internship opportunities at the clinical research site
- Several recruiters recruiting CDM professionals
- 100% Job assurance and complete support until you get placed
Along with being a full-fledged research center that conducts clinical operations strictly adhering to standard practices and protocols, Lifepoint is also a multi-specialty hospital. Equipped with the latest technology, it has 116 beds and a medical setup that speaks for itself. In addition, it delivers services in therapeutics like Cardiology, Orthopaedics, Endocrinology, Oncology, ENT, Ophthalmology, and many other areas.
With such versatility and in-house expertise, you can only imagine how efficient a clinical data management course in Pune would be. Not to mention, Clinical Data Management is a highly specified area. So, when you choose to pursue this course, you must pursue it from the best in the industry.
