CLINICAL DATA MANAGEMENT

CLINICAL DATA MANAGEMENT

      Clinical data management is a great opportunity to the medical professionals and also to them who are willing to go the corporate sector wherever he or she doesn't need to have marketing or engineering background. In the second case, he or she need to have the proper knowledge and experience about some software like Oracle, SAS, SPSS etc. It has been reported that a lot of reputed companies such as Zidus, cadila, Cipla, GlaxoSmithKline, TCS, IBM, Accenture etc are found to recruit major candidates for such kind of this job.There are many opportunity like data manager, data programmer, Program data leader, Study data manger. Actually their job is collecting the data from clinical research site and cleaning them and management the accepted data to help achieve the decision of clinical study about investigational products which are helpful to treat the disease or not.

Clinical data management

     Clinical data management (CDM) is a process that manages clinical data to produce a high quality, clean and analyzable database. It is the process of collecting, entering. cleaning and reporting on the data received from clinical trial. Data management involves in aspects of Clinical trial data processing, working with a range of computer application using such software like SPSS, SAS, Oracle and database system to support collection, cleaning and management of subject or patient data.

Importance of clinical data management - 

• To provide  consistent, accurate and valid clinical data.
• To support the accuracy of the final report.
• CDM is a vital vehicle in clinical research to make ensure about the integrity, purity and quality of data being transferred from trial subjects to a database system. 

CLINICAL RESEARCH RESPONSIBILITIES

RESPONSIBILITIES IN CLINICAL TRIAL

       Clinical trials or Clinical research is a process by which new pharmaceutical molecules, medical devices and biologically active agents are evaluated for safety and efficacy and utility to ascertain whether actually they help to treat a disease or not.

     

Clinical Research

       There are mainly three type of personnel who are responsible for conducting clinical trial.

They are Sponsor, Monitor and Investigator.

       Sponsor- The sponsor has to find out the institute or center or hospital where clinical research study site and facilities are available.The investigator is to be selected by the sponsor as per as educational qualification or experience. Before agreement The sponsor should provide a complete information brochure to the investigator or the institution.

      The sponsor confirms the contract with the investigator in the following terms:-

• To conduct the trial in the compliance with GCP.
• To comply with the procedures of data processing such as data handling, data recording and data reporting.
• To give the allowance of monitoring and auditing. 

     The sponsor has the responsibility to provide a Standard Operating Procedure(SOP). The sponsor gives the total information about investigational product which is to be decided for clinical trial. Such information like pharmacological, toxicological, chemical constituent and preclinical data should be accurate to justify the nature and duration of study. The sponsor is also responsible for safety evaluation of the product to be studied.

   Monitor- It is a communication link between the sponsor and the investigator. 

• The monitor should verify the capability of the investigator and the facilities in the institute to conduct the study.
• The monitor should check the availability of the investigational product in specific dose.
•  The new molecule provided to the subject (known as a person who receive the new molecule) in specified time.
• The monitor has the responsibility to ensure the study is conducted as per as Good Clinical Practices (GCP) Guideline and SOP.

  Investigator-  The investigator should be ensure that the proper care is provided to the subjects for any adverse events during the study.The investigator should select the subject which is exactly appropriate for the study. the investigator should ensure the accuracy and completeness of the data from the clinical study which is to be provided to the sponsor.
     
      After all the data is received the clinical research organization can be able to achieve to the decision that the new molecule or biologically active agents are still important to treat the disease or not.

CLINICAL RESEARCH

 

CLINICAL RESEARCH OPPORTUNITY

 

        Clinical research is a excellent opportunity for life science graduates. Clinical research means a new chemical molecule may be it is drug or not is to tested in human body to make sure it is drug to treat the particular disease. After clinical trial it will be said as drug. Any life science graduates like Pharmacy, Nurse, MBBS, BDS etc. can be a part of clinical research. Your role is here to help the researcher to discover the actual dose to treat the disease in better way, prevent, cure, diagnose and understand the human disease.

 

Clinical research programme

      Here this chart shows the list of opportunities for the clinical research professionals. A MBBS or BDS generally is to recruited in charge to figure out the whole process of clinical trial and decide how the trial is to be going on. Other graduate professionals helps him to gather information during clinical trial to find out the effective dose. The role of clinical data management is to entry of manage data which helps to decide actual what dose will be safe for the particular disease. In the last phase of clinical trial is Pharmacovigilance where the test drug is provided to pharmaceutical companies to sell for the purpose to know how it responses in general people.

     As per as Clinical research Centre watch estimates, the global clinical trials industry is currently worth an estimated $15 billion and has potential for considerable growth in the future. Global revenues from clinical trials have increased by almost 15% in the last year and the industry is prepared for an extended period of healthy growth. 



PHARMACY

 

PHARMACY CAREER

 

 

       Pharmacy is one of the popular medical professions in the world. Now-a-days there has been seen money fall in corporate world wherever medical profession sounds good. The candidate who are thinking about career in medicine world rather than being a doctor, must choose Pharmacy career.

Pharmacy logo

 

      Pharmacy deals with the science of  compounding and dispensing of medicines. It is an art of  preparation of medicine from natural and synthetic sources, suitable materials for packing and distribution and use it for treatment to cure disease. The role of pharmacist is to provide a vast knowledge of identification, selection of perfect dose, analysis of drug, pharmacological action, formulation and preservation of drugs.

Dosage form

     There is a variety of opportunities after completing this course. There is a great career to be medical representative in all multinational medicine companies like Glaxosmithkine, Cipla, Cadila, Ipca etc. Another opportunity to prepare formulation, analysis of pure drug in dosage form in various reputed industries, present worldwide. And someone can pursue for higher study in master degree or doctorate after graduation and will achieve a bright future to be scientist .



AYURVEDIC PHARMACY

 

AYURVEDUC PHARMACY

 

       Ayurveda is known as the science of life and is based on the principle of "maintaining the health of a healthy person and relieving the patient from the disease condition". The object of Ayurveda is to counteract the imbalance of three essential elements i.e. Vaata, Pitta and Kapha (air, bile and phlegm respectively),which constitute the Toridosh from which the body originates. It is the Toridosh which regularises the normal working of the human body.

       According to hypothesis of Ayurveda, the entire universe is composed of five basic elements called PANCHMAHABHUTA and include space (akasha), air (vayu), energy (teja), liquid (jal) and solid (prithvi). The variable combinations of these principles make tridosha in human body. These are vaata, pitta and kapha.

Ayurveda

 



Vaata- It is concerned with the physical and mental activities which are activating and represents nervous system.

Pitta- It dominates nutritional and thermogenetic activities and also includes hormonal, digestive and metabolic systems.

Kapha- It is composed of solid and liquid and indicates various tissues and organs.

 

Ayurvedic profiles of Herbal Drugs (A few examples are given below):

1. NEEM-It is a bitter tonic and used as insecticide.
2. BRAHMI-used as brain tonic.
3. PALASH-It is an astringent and used for treatment of diarrhoea and dysentery.
4. KALLIJIRI-Anthelmintic, tonic, stomachic.
5. AMLA- used in Vitamin C deficiency. 
6. TULSI- expectorant, antiseptic.
7. OPIUM-narcotic.          

CLINICAL TRIAL MANAGEMENT SYSTEM

 

CLINICAL TRIAL MANAGEMENT SYSTEM (CTMS)

 

 

       A Clinical Trial Management System is a customizable software system used by the biotechnology and pharmaceutical industries to manage the large amounts of data involved with the operation of a clinical trial. It maintains and manages the planning, preparation, performance and reporting of clinical trials with emphasis on keeping up-to-date contact information of participants for regulatory approval of new drug molecule.

 

Clinical Trial Management System

 

A clinical trial management solution provides the following benefits:

• Design and prototype trials faster and easier.
• Increase the speed and accuracy of data entry.
• To make electronic data capturing, data management and adverse effects reporting.
• More effective Data Management and Analysis
• To perform administrative tasks, issues, schedules.
• Integrate with budgeting and finance applications.
• Provide sites with online access to sponsor and CRO(Clinical Research Organisation) information, documents and frequently asked questions (FAQs).