Clinical Research Courses Create Better Auditors for Clinical Trials

Need for Qualified Audit Teams

 An integral part of modules in clinical research courses  focus on the ethical standards that have to be implemented without compromising the quality of trial results. This necessitates the establishment of a good quality assurance team that will be able to deliver excellent outputs to the various project sponsors by focusing on Good Clinical Practice guidelines as per global standards.

Importance of Quality Assurance in Clinical Trials

It is essential for the audit teams to not overlook the aspect of quality assurance in the field of clinical research. The first reason being that the sponsor would experience major losses if there is either a delay in project development or getting inadequate results. Also, the effects would be detrimental as there could be legal issues as well as impact on human health.

Incorporation of Good Clinical Practices for enhanced clinical trials

The Good Clinical practices makes certain that the design, implementation, monitoring, auditing, recording, reporting and analysis of clinical trails are managed in a better manner

Good Practices Followed in Clinical Trials

There are numerous Quality Assurance -focused good practices followed by Clinical Research Organizations (CRO’s) in clinical trials. They are:

Ø  Assimilation of Quality Culture in Audit Teams

If a set of shared, accepted and integrated pattern of quality are assimilated in the project personnel, then members handling different responsibilities will ensure that they achieve quality parameters. Moreover, the professionals would work together as one unit to implement quality assurance. Therefore, OA analysts will be at ease to deliver higher number of quality trials

Ø  Implementing Quality in Design

Both the project sponsor and the clinical research Organization should collaborate and design the project in such a manner that each stage of the process has a component for quality checks of the trials. Furthermore, several Quality Checks should be conducted regularly such that errors should not be overlooked. The reason being that the longer it would take to discover the error; there are more chances of detrimental effects on the safety and efficacy analysis of the clinical trial.

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Respecting the Subjects Involved in Clinical Trials

It is an irrefutable fact that clinical trials are conducted after the subjects meet specific parameters for ensuring their suitability in trial participation. However, the quality assurance for clinical trials also takes up the responsibility to acquire subjects that are in compliance with the protocol for the project. Nevertheless these subjects have to be treated with utmost respect and should be treated within the limits of ethics.

Audit Teams ensure compliance of guidelines

Most importantly, clinical trials, audit teams run audits for protocols, SOPs,   guidelines for Good Clinical Practices and other nation-specific guidelines.  Therefore, it is the duty of the audit team to run internal audits during the drug development process in order to review documented trial data.

In conclusion, the audit team plays an integral part in implementing quality assurance in the field of clinical research from the initial stage to the final stage. These audits assist the project team member’s to evaluate the entire clinical trial, rectify issues on timely basis and enhance the processes for further trials.

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Clinical Research Courses! How Clinical Data Is Captured in the Industry

Introduction:

The clinical research industry is a booming industry because there are several research studies being conducted all over India. These research studies are conducted by qualified experts who have enrolled in clinical research courses to gain adequate knowledge about their field. This helps them in gathering clinical data effectively as it is a key element of medical research. This data is either during the course of ongoing patient care or during formal clinical trial.

Elements and Types of Clinical Data

Medical Data is the health-related information that is connected with regular patient care or a clinical trial process. There are many categories of clinical data that are recorded during the process of clinical trials. They are

                    

I.            Electronic Health records

Electronic Health Records is considered to contain the best form of data captured by healthcare professionals as they include information of great significance .An electronic health record comprises of a digital record of a person’s medical history as well as history that is recorded on a timely basis by the healthcare provider

Medical data found in an electronic health record can include:

Ø  Records of vital signs like heart rate, respiratory rate, and temperature.

Ø  Diagnostic-related information, like laboratory test results from blood tests, genetic tests,  and x-rays

Ø  History of the current medication regime regarding to the amount and duration of medication taken by a patient.

            However, these sensitive details are not available to outside researchers

              

   II.             Administrative Data

It comprises of data that is non –clinical in nature .This data mainly focuses on keeping records of a service that are required by government agencies. For an instance, a hospital’s record of administrative data would consist of the discharge information of a patient

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III.            Claims Data

               

 The third type of data is Claims data that are recorded and generated primarily for the administration of payment for health services delivered by healthcare providers and facilities.

Patient /Disease registries:

The fourth type of data us that of disease registries that track a narrow range of key data  for certain chronic conditions for Alzheimer’s disease, cancer, diabetes, heart disease and asthma .These registries contain informative data that would help understand and address chronic cases effectively .

              

  IV.            Health Surveys

It is the systematic collection, analysis and interpretation of health data that is essential for the design, implementation and evaluation of public health programs. These surveys generally include of risk factors and health behavior .In addition to that, it includes no health determinants or correlates of health such as socioeconomic status.

                 

V.            Clinical Trials Data

Clinical Trials Data consists of a data base of clinical records covering numerous disease areas in countries across the globe over a timely basis. Generally, clinical trial data consist of several clinical trials that have been assimilated into a single database.

Healthcare professionals can be promised of a lucrative career after getting certifications. Given below are some job profiles that one could get in the field:

1.       Clinical trial Assistant

2.       Clinical Research Associates

3.       Clinical Research Analyst

To conclude, the healthcare professionals who are part of a clinical trial not only land their dream jobs but also get a chance to give back to society, therefore, it would be useful for professionals to enroll in clinical research courses in order to grow in their career

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Clinical Research Courses Benefit Clinical Trials in Many ways

Rise of Research Centers in the Country

There is an increasing demand for clinical research courses  in the country .The reason for this demand is that medical research has become an important part of the Indian economy. Presently, India is witnessing tremendous progress as several multinational pharmaceutical firms are setting up centers and introducing many research programs in the country. Furthermore, The Government of India has always offered its support to these research endeavors. Therefore, it is essential to efficiently explore the authenticity of the treatment, medical strategy and equipment.

Establishing Clinical Operation Services to deliver successful trials

Since, clinical research determines the safety and efficacy of drugs, devices and treatment regimens for human use, it was important to establish a process that would focus on the delivery of clinical trials. This led to the establishment of Clinical Operation Services. Without Clinical Operations, Clinical Research activity could never take place in the industry. Clinical Operations teams are responsible for designing, planning and implementation of all four phases of clinical trials

Advancement of Drugs in the Medical Sector

For the uninitiated, clinical trials are a key research tool for advancing medical knowledge and patient care. Clinical trials, also known as clinical studies, test potential treatments in human volunteers to see whether they should be approved for wider use in the general population. The treatment could differ for every patient because every sickness has different implications. For instance the treatment regime could be either a drug, medical device or a vaccine. The benefits may not be known unless the healthcare professionals are done with the trials, Therefore professionals go through clinical research courses to gain an understanding on the process and development of better drugs

Advantages of Clinical Trails

On one hand, there are various benefits that the volunteers plus clinical research industry gains through a clinical trial. They are:

• The opportunity  for a volunteer to be the first to benefit from a new method under research
• A chance to contribute to society by being an integral part of a new trial.
• Receiving treatment that may be more effective than the regular one.
• Access to promising new treatments which are not available outside the clinical trial setting.

·         Close monitoring, advice, care, and support by a research team of doctors and other health care professionals who are aware of the patient’s condition. Therefore it is important for the professional to get a certification in clinical research to carry out their responsibilities

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Risks of Clinical Trials

On the other hand, clinical trials include several risks. They are:

•  The experimental drug may not have the same effectiveness for all patients
• Volunteers  may experience some serious life threatening  side-effects as a result of the trial Method
• The involvement in the clinical trials may include frequent visits to the lab compared to those of non-clinical trials.
• Volunteers  may be asked to stay back in the hospital for extended hours to be kept in observation

To summarize, Clinical research is being enhanced with the aid of the latest technologies, government facilities and improved regulations. Clinical research has opened up many lucrative job and business prospects in Clinical Operations, Medical writings, CDM, Pharmacovigilance. Therefore, after completing clinical research courses, capable professionals are getting an opportunity to showcase their talent in the field of research with an aim to serve the mankind in a better way.

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Significance of Clinical Research Courses in Clinical Trials

Introduction

Several health professionals may question the need of enrolling themselves in clinical research courses that specialize in pharmacovigilance. The reason of this requirement is the demand of qualified professionals to carry out research to find new drugs that provide relief to sick patients. Therefore, various pharmaceuticals companies use a trial population to conduct clinical research, In addition to that, pharmacovigilance services are utilized by the pharma companies in clinical trials for drug development. Thus, professionals need to pursue clinical research courses to gain a thorough understanding of the industry.

Listed below are the reasons why pharmacovigilance services in India are important for clinical trials:

Ø   Ensuring Safety of Trial Participant

Firstly, safety is the utmost concern in clinical trials. Pharmacovigilance services are important because they support the project team to adhere to safety standards that protects the identity and well-being of the trial participants. Besides that, stringent laws are present across the world to make sure that safety is the topmost priority in several clinical trials. However, ethical companies hire reliable support services to follow these laws as well as to encourage a fair trial for drug development.

Ø  Conducting of Safety Adverse Events (SAE)

Safety Adverse Events (SAE) Reporting can be a cumbersome process. However, the process is vital as it is required by regulatory authorities in many countries across the globe. These reports are formed by pharma companies by collating data from various sources such as trial participants, regulatory resources, media reports, and other literature. Therefore, professionals need to enroll in clinical research courses to carry out their tasks effectively.

Ø  Creation of Risk Benefit Profiles

Clinical research professionals create a risk profile of the drug which includes its harmful effects, precautions for consumption, warnings etc. This profiling includes details of the trial participants, their response to the drugs, etc.  The Adverse Event Reporting process also helps authorities and project sponsors to determine the risks and benefits involved in producing a drug. In addition to this, the risk benefit profile gives a clear picture of whether the risks outweigh the benefits or not.  Moreover, Regulatory authorities look for a positive risk benefit profile with a balance between risks and benefits as per the guidelines. Therefore, professionals should enroll in clinical research courses to understand risk profiles

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Ø  Maintenance of  Safety Records

Case Safety Reports (CSR) is reports comprising of the adversities faced by each individual who was part of the trial as a participant. After the relevant data is used for the existing project, these reports are archived for future projects. Clinical Research and Pharmacovigilance services in India are undertaken by well-qualified and experienced clinical research professionals. They not only help you to maintain safety records of each safety incident. In addition to this, they help you in preventing similar safety lapses through insightful reports.

To put it in a nutshell, Safety Adverse Events reporting is a critical step in drug development. Authorities study SAE reports and other drug development documents carefully. Service providers assist project sponsors by collating all the necessary documents that is to be sent for drug evaluation by authorities. And to conclude the process, the evaluation process will lead to the acceptance or rejection of the drug which will determine whether drug will be produced for the masses or send back to the lab for further research.

To conclude, pharmacovigilance services in India. Their expertise and understanding of the drug development process makes it easier for pharma companies to roll out useful drugs in the safest possible manner. Therefore, professionals need a certification in clinical research to gain expertise in the industry.

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Clinical Research Courses Open New Avenues in Pharmcovigilence

Introduction

Pharmacovigilence is allied to the fields of life sciences and pharmacy.  It is defined as the science and activities relating to the detection, assessment, understanding and prevention of adverse effect or any other drug-related problem. To put it simply, the role of this scientific discipline is to examine the side effects of drug and monitor the safety of drugs that are available in the market. Whenever any adverse effect is reported, the pharmacovigilance professionals are the ones who follow up with the various developments of the case and carry out the necessary tests. Now there is new twist industry to master the filed, there are now clinical research courses which help the candidate in the industry to grow better.

Eligibility Criteria to Pursue a Career in Pharmacovigilance

A clinical research professional  needs to possess a life sciences degree such as botany, zoology, biotechnology, microbiology, biochemistry, genetics,  to be eligible  for a career in Pharmacovigilance  One can also go in for a career in  pharmacovigilance with chemistry as their subject  either at postgraduate or undergraduate level. However, the individual needs to score a minimum of 50%.

Clinical Research Courses expand your knowledge in Pharmacovigilance

After their graduation, It is essential to pursue a certification course in clinical research and  pharmacovigilance from a clinical research training institute .The best training courses in clinical research and pharmacovigilance offer industry-oriented  training which is conducted by teams of corporate experts with several years of experience in the clinical research and pharmcovigilence industry

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Scope of Pharmacovigilence

India is one of the largest producers of pharmaceuticals in the world. There are thousands of licensed drug manufacturers in India which will recruit pharmacovigilance professionals in large numbers. Apart from the opportunities in the country, professionals would find opportunities worldwide.

Career Prospects in Pharmacovigilence

The pharmacovigilance industry always struggles for qualified medical talent which suits to the needs of the drug safety enterprise. One could land a job in pharmacovigilance after completing the best courses in clinical research and pharmacovigilance. Moreover, the pharmacovigilance job profiles have the ability to unleash a professional’s true potential and eventually they go up the corporate ladder swiftly.

With the pharmacovigilence industry growing at a rapid rate, professionals will find many job opportunities in pharmaceutical companies along with a few positions in the public sector.

Salary Package in the Pharmocovigilence Industry

After completing certificate or diploma courses in pharmacovigilance, one can start their career in this profession with more than 2.5 lakh per annum. In a duration of five years, the pay scale of the professional will go up to 5 to 8 lakh per annum

Roles and Responsibilities of Pharmacovigilance Officers 

          

The roles and responsibilities of a pharmacovigilance officer include:

Ø  Recording and reporting adverse reactions received from healthcare professionals and consumers

Ø  Conducting in-depth interviews with patients and healthcare professionals

Ø  Developing a thorough understanding of products

Ø  Completing periodic safety update reports on drugs and other treatments

Ø  Writing and reviewing serious adverse effects reports and forms

Ø  Flagging up early warning signs of adverse effects of drugs

Ø  Mitigating  the risk of serious side effects

Ø  Completing safety audits

Ø  Working on clinical trials of new drugs

Pharmacovigilance officers are employed by the following companies:

Ø  Pharmaceutical

Ø  Medical device companies

Ø   Biotechnology companies

Ø  Regulatory authorities

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A Guide to become a Clinical Research Associate (CRA)

Significance of a Clinical Research Associate

The clinical research sector is a booming industry not only in India but around the globe as well. A wide range of clinical trials are being conducted due to the elderly population, prevalence of illnesses such as diabetes and cancer and new developments in research. Therefore the part of a clinical research associate is very important as he or she plays a role in the development of new drugs, treatment protocols or new devices.  Once, a person gains entry into the clinical research industry after pursuing clinical research courses ,training and certification from a renowned clinical research training institute he or she would find many opportunities to travel ,work with big names in the industry and unleash his true potential.

 How one can go for a Clinical Research Associate Profile?

The first step towards becoming a Clinical Research Associate is to enroll oneself in courses in clinical research and pharmacovigilance, get industry oriented training and a certification in clinical research and pharmacovigilence from a recognized clinical research training institute.

Get Experience in Practical Knowledge

A student also needs to keep in mind that   along with theoretical knowledge, a clinical research institute that offers live practical training and various case studies would be the best clinical research training institute . Therefore, by being a part of these studies and projects, you would gain hands-on experience in order to be capable to carry out your tasks in the corporate world

Polish your soft skills

Apart from monitoring the research process, it is vital for a Clinical Research Associate to excel in both oral and written communication as well as computer literacy. One needs to polish these soft skills to excel in the industry. Apart from that, one can ensure that they attend personality development sessions with the corporate experts at their clinical research training institute so that they will be suitably trained for a career in the corporate world.

After a professional’s entry in the corporate world, one would be carrying out the following roles and responsibilities

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Roles and Responsibilities of a Clinical Research Associate

•       Identifying an investigator who will be responsible for the conduct of the trial 
•        Laising with doctors/consultants or investigators on conducting the trial.
•     Setting up and ensuring that trial centers are equipped with essential trial materials.
•      Training the study staff in standard procedure for  clinical trials in  compliance  with regulatory requirements.
•       Monitoring the trial throughout the entire trail by constantly visiting the trial sites.
•         Writing visit reports, filing and collecting trial documentation and reports.

Further Prospects as a clinical research associate

After working as a clinical research associate, clinical research associate can aspire to be Lead Clinical Research Associates, Head of Clinical Research. Project Manager. Director of Clinical Operations. There would also be different opportunities in the pharmaceutical research-and-development sector for positions in pharmacovigilance, regulatory affairs, and marketing.

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Definition of Clinical Research                                 

Clinical Research is a sub-stream of life sciences where research is carried out to understand health and diseases in human beings. To express it in simple words, comprises of human participants and helps convert basic research conducted in laboratories into novel treatments and data which can be used to benefit patients. Besides clinical trials, research in epidemiology, physiology and psychopathology, health services, education, outcomes and mental health all come under the canopy of clinical research.    

                       

Scope of Clinical Research

At present, the clinical research industry is growing at a fast pace and creating more demand for qualified clinical research professionals. The reason for these massive demands is the existence of the aged population, new developments in research and the prevalence of illnesses such as cancer and diabetes. Scope of clinical research is so vast that, now there are so many institutes which guide the candidate to be best in the field, their clinical research courses has some serious impactful knowledgeable content which leads candidate to its destination.

 In addition to this, the wide range of clinical trials being conducted in labs as well as the expansion of clinical trials have led to the requirement of competent clinical research professionals in clinical trial management, clinical data management and authorities regulating ethical issues related to clinical research, Future of Clinical Research.

The clinical research industry has been in existence since the early 2000’s. Nonetheless, there is a lack of awareness about the clinical research industry in general. Having said that, healthcare industry professionals need to have expertise to carry out their daily tasks .Hence, they need to enroll themselves in a clinical research course, undergo industry- oriented training and get their certification from a recognized clinical research training institute.

Once the student has completed the course, he or she would experience various rewarding career prospects in the clinical research industry.

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Career Prospects after Clinical Research Courses

The three sectors of the clinical research industry offer lucrative job profiles after the completion of various clinical research courses. Given below are the few job profiles found in the industry:

•    Clinical Research Associate
•  Clinical Trial Associate
•   Medical Coding
•   Medical writer
•  Medical & Regulatory officer
•  Manager –Safety / Patents
• Data Analyst Pharmacovigilance
• Regulatory Affairs Executive                                                               
• Clinical trial auditor
• Clinical trial writer

In addition to this, here are the various sectors where one would find various job opportunities:

•    Clinical CRO(Contract Pharmaceutical Companies)
•  Biotechnology Companies
•   Clinical  Data Management Companies
•   IT companies in Healthcare
•  Medical and Regulatory Officers
•  Data Management CRO’s
•  Packaging , Labeling and Contract Manufacturers

                                                                                                      

Package of a Clinical Research Professional:

The package of a clinical Research professional would depend on the job profile of the healthcare individual. Generally, the salary package after completing a Clinical Research course is has the starting annual package of 1.8L to 4.8L annually.                                                              

Therefore, to become a competent clinical research professional, one needs to take admission in clinical research courses

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