Clinical research training in hyderabad ikyaglobaledu

Clinical Clinical ResearcResearch and h and

Clinical Clinical Data Data

ManageManagement ment

TrainingTraining

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. For more info visit http://www.ikyaglobaledu.net

Investigations involved in clinical trials are carried out in conformation with formal protocols that determine exactly how the trials are to proceed. Clinical Research Training in Hyderabad

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.

The science of clinical research is different from that of clinical practice.

The trials The trials are are

carried carried out in out in

phases. phases. The first The first

phase phase involves involves

the the testing of testing of

a new a new drug, drug,

device or device or treatment treatment in a small in a small group of group of subjects subjects

to to determine determine its safety, its safety,

safe safe dosage dosage

range and range and side-side-

effects. effects.

Phase 4 is the Phase 4 is the stage in which stage in which

studies are studies are conducted conducted

after a after a treatment or treatment or

drug is drug is distributed distributed

across across populations to populations to

find out its find out its long-term long-term effects and effects and side effects.side effects.

•The next phase The next phase involves the involves the administration of the administration of the drug to a larger drug to a larger number of subjects number of subjects so that the so that the treatment’s efficacy treatment’s efficacy can be ascertained can be ascertained and its safety and its safety established. established.

•In the third phase, the In the third phase, the treatment is treatment is administered to a large administered to a large population of human population of human subjects to confirm its subjects to confirm its efficacy, find out its efficacy, find out its side-effects, to side-effects, to compare it with other compare it with other current treatment current treatment options, and to confirm options, and to confirm its safety. its safety.

Clinical data mClinical data management anagement is that aspect is that aspect

of clinical of clinical research that research that

involves involves clinical data clinical data

entry, entry, validation, validation, verification verification and quality and quality control of control of

data data associated associated

with clinical with clinical trials. It is a trials. It is a

critical critical aspect of aspect of clinical clinical

research in research in which which

statistically statistically relevant data relevant data is collected is collected

from clinical from clinical trials for trials for research research

purposes. purposes.

Clinical data Clinical data managementmanagement

(CDM) (CDM) involves involves various various

activities that activities that include include

designing and designing and creation of creation of case report case report

forms (CRF), forms (CRF), annotations, annotations,

data data validation, validation, data entry, data entry,

data data extraction and extraction and

quality quality assurance. assurance.

It relies on a large number of skill sets ranging from scientific, technical, to IT, engineering and even interpersonal skills.

CDM CDM involves the involves the

use of use of various data various data managemenmanagement tools, most t tools, most of which are of which are web-based. web-based.

Those Those wishing for wishing for a career in a career in CDM need CDM need

to be able to to be able to conform to conform to stringent stringent

regulations regulations and and

protocols. protocols. Data Data

managemenmanagement needs to t needs to

be error-free be error-free in order to in order to ensure the ensure the validity of validity of

the research the research findings. findings.

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.

The The training training may also may also include include

internship internship programs programs

and on-the-and on-the-job job

training. training. These These

courses courses have a have a

great scope great scope for those for those

interested interested in the field in the field and have and have

the the necessary necessary backgrounbackgroun

d d qualificatioqualificatio

ns. ns.

In order to ensure job guarantee, students should make sure they develop their personality, communication and interpersonal skills. Visit http://www.ikyaglobaledu.net

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.

Courses Courses taught bytaught by

Clinical Data Clinical Data Management trManagement training instituteaining institutes in Hyderabads in Hyderabad cover various cover various topics on the topics on the

subject. subject.

A good course module A good course module should include case should include case report form design, report form design, central laboratory central laboratory data, clinical trial data, clinical trial

monitoring, clinical monitoring, clinical trial preparation, trial preparation, compliance and compliance and

audits, computer audits, computer system validation system validation (CSV), data entry, (CSV), data entry,

data management and data management and biostatistics, data biostatistics, data management plan, management plan, data queries, data data queries, data

validation, database validation, database design and build, design and build,

database finalization database finalization and extraction, and extraction,

epidemiology and epidemiology and evidence based evidence based

medicine, essential medicine, essential documents and documents and

regulatory regulatory submission, ethics in submission, ethics in

clinical research, clinical research, financial management financial management

of clinical trials, of clinical trials, general introduction, general introduction, medical device trials, medical device trials, metrics and tracking, metrics and tracking, other external data, other external data,

patient recorded data, patient recorded data, personality personality

development and development and communication skills, communication skills,

pharmaceutical pharmaceutical medicine, medicine,

professional professional organizations for organizations for

clinical data clinical data management, project management, project

and vendor and vendor management, quality management, quality control, regulatory control, regulatory affairs in clinical affairs in clinical

research, role of the research, role of the clinical data manager clinical data manager

in a clinical trial, in a clinical trial, roles and roles and

responsibilities, responsibilities, serious adverse event serious adverse event

reconciliation, reconciliation, standard operating standard operating procedures, study procedures, study

start-up, therapeutic start-up, therapeutic areas, user areas, user

acceptance testing, acceptance testing, and validation rules. and validation rules.

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.

Placements Placements depend depend

solely on the solely on the skills skills

exhibited by exhibited by the job the job seeker. seeker.

Additional Additional skills that skills that

can be can be acquired by acquired by

those those seeking a seeking a job in the job in the

field include field include knowledge knowledge of Encoder of Encoder Pro, typing Pro, typing

test test software, software, and Live and Live Charts. Charts.

There is no There is no specific specific

eligibility eligibility requirement requirement

for the for the course. course.

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.

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.

Some Some institutes institutes offer their offer their

own own certificationcertification

s while s while others offer others offer certificationcertifications from other s from other

bodies. bodies. Irrespective Irrespective

of the of the course course

taken or the taken or the certification certification

sought, sought, students students should should

strive to strive to develop develop

their soft-their soft-skills as well skills as well

as their as their industry-industry-

based based knowledge if knowledge if they wish to they wish to further their further their

careers or careers or acquire acquire

employment employment easily. easily.

Among the Among the various various

institutes for institutes for Clinical researchClinical research and Data Mana and Data Management training gement training in Hyderabadin Hyderabad, , IkyaIkya Global Global EduEdu is one of is one of

the key leaders the key leaders in the industry. in 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.

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