The document outlines the field of clinical research and clinical data management training, emphasizing their roles in assessing drug safety and efficacy through structured trials. It details the phases of clinical trials and the various skills required for effective data management, including software proficiency and adherence to regulations. Additionally, the document highlights the importance of choosing reputable training institutes, developing soft skills, and understanding that job placement depends on individual capabilities rather than guarantees.

1. Clinical Research and
Clinical Data
Management Training

2. 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.
Clinical Research Training - Ikya

3. 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
employs established treatments while
clinical research establishes a
treatment.
Clinical Research Training Institute - Ikya
The science
of clinical
research is
different
from that of
clinical
practice.
Investigations involved in clinical trials are
carried out in conformation with formal protocols
that determine exactly how the trials are to
proceed.

4. 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.

5. 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.
Clinical Research Course
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.

6. 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.

7. 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.

8. 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.

9. 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.
Most training
institutes offer
integrated
courses for
clinical
research and
clinical data
management,
which may also
include SAS
training.

10. 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.

11. In order to ensure
job guarantee,
students should
make sure they
develop their
personality,
communication and
interpersonal skills.
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
are 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.

12. Courses taught by Clinical Data
Management training institutes in
Hyderabad cover various topics on the
subject.

13. 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.

14. No training institute
can offer 100%
placement guarantee
but can offer 100%
placement
assistance. So one
must stay away from
institutes that claim
100% placement
guarantee.
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.

15. 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.

16. 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.
However, it is
advisable that
those seeking
this course
should come
from a life-science
background.
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.

17. 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.

18. 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.
Clinical Data Management Training.

19. 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.
The
training
institute
offers
100% job
assistance
and has
trainers
from the
industry.