Human Cloning & Its Types

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Cloning is defined as “the technique of producing a genetically identical copy of an organism by replacing the nucleus of an unfertilized ovum with the nucleus of a body cell from the organism”. The first animal that was cloned successfully was a sheep and it was named Dolly in 1997. The cloned sheep, Dolly was exactly similar to the naturally conceived sheep. The only difference between the two was: Dolly’s embryo was developed without the presence of sperm.

Dolly’s birth has brought a marked revolution in the genetic engineering technology. Over the years scientists have duplicated many non-human animals like mice, pigs, cows, dogs, monkeys etc. The research has extended to human cloning, but since years human cloning technology has remained in infant stages as there are many ethical concerns involved. Let us discuss how human cloning is done and what are the steps involved in it. Continue reading

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Clinical Research Course in Egypt

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Clinical Research business is a growing industry in the middle east. Having explored the benefits of conducting clinical trials in developing nations such as Latin America, India and China, pharmaceutical and biotechnology companies actively involved in conducting clinical research are now getting attracted towards the middle east as a destination to outsource clinical trials.

This has resulted in an increase in the number of hospitals and private clinics that conduct human research phases of drug development in Egypt. This increase has also led to availability of more jobs and career options in the area of human research / clinical research. Still in a nascent stage this industry is looking for professionals especially medical doctors and pharmacy graduates who are trained in clinical research and allied specialities who can take charge and be in control of the ongoing human research. The clinical research industry in Egypt is looking for professionals who have documented evidence of training in clinical research and can efficiently conduct clinical trials as per the local and international guidelines and regulations available for conducting clinical trials.

If you are a doctor / physician / pharmacy or any other science background student from Egypt, you must explore clinical research as a career option. Globally recognized online training programs in clinical research offered by James Lind Institute in Egypt are great value addition professional development programs that add immense value to your personal profile and also equip you with the skills and knowledge that is expected of clinical research professionals. We encourage you to contact us to know more about clinical research and how online training programs can help you shape up your career and research aspirations.

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Cell Phone Technology in Clinical Trials: Mobile Patient Reported Outcomes (mPRO)

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Cellular/ mobile phone has become an essential part of life in this modern world. A recent survey states that the number of worldwide cell phone users would reach 6 billion compared to the Internet users whose number is 32.7% of world’s population, by the end of 2012. The cell phone technology is added with many advanced applications into various fields. One of the major applications of cell phone technology is in the clinical research domain.

Till date, web technology is being used for certain applications in clinical research. Now the cell phone technology is being implemented in some applications like patient reported outcomes (PRO). FDA defines a PRO as a measurement of any aspect of a patient’s health status that comes directly from the patient (i.e., without the interpretation of the patient’s responses by a physician or anyone else). Let’s have a brief explanation of using the mobile technology in PRO. Continue reading

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Clinical Trial Investigator Meetings

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Investigator meeting is an event that makes all the principal investigators and researchers to meet in person at one place to discuss and to get trained about the clinical study protocol. The sponsor hosts the investigator meeting and provides hands-on training and orientation for the investigators and study coordinators. The purpose of the investigator’s meeting is to introduce one researcher to the other on a single platform where every investigator is introduced to the research study as a whole and get trained in appropriate study conduct.

The investigator’s meeting is conducted prior to the first patient screening at any clinical site. Further, the clinical trial material is supplied to all the clinical sites only after the investigator’s meeting is conducted. This shows that only after receiving hands-on training in appropriate study conduct, the investigators were given access to the clinical study material. Continue reading

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Quality Management in Clinical Research

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Quality Management has been a part of every industry over last many decades. The concept has evolved and refined over the years and has also changed the outlook of the industry. Hence, it is no surprise to consider it of prime importance in the clinical research arena.

Since this industry puts in lots of efforts in shortening the length of time that it takes to develop a molecule which is safe and efficacious to be used in humans, to value such a complex procedure we need a thorough understanding of the subject. The strict timelines to bring the product to light and to capture the essence of the market has started a fierce competition within the pharma sector. The finished products after all need to be valid and should be competent. To achieve this target the research arena is well regulated with guidelines and laws.

Quality in clinical research is to be kept as a prime motive with our focus on guidelines and laws and respecting them with a strict implementation. Documenting everything is the thumb rule and this should be in-line with guidelines, regulations and the Standard Operating Procedures. The department of Quality Assurance has gained a lot of importance in the last decade because of the cited reason.

An effective Quality Management system for clinical research helps to ensure that research is planned, conducted, analyzed, reported and managed in compliance with guidelines, regulations, SOPs and is also protecting ethical rights of a subject. Quality at every step while conducting research can only give us quality results.

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Ten major considerations while participating in a Clinical Trial

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Following are the ten major considerations (questions to ask) before participating in a Clinical Trial. It is a Patient’s Perspective of What You Need to Know.

1) Where do the ideas for clinical trials come from?
The ideas for clinical trials are proposed by researchers. Every new drug research is at first tested with many procedures in the laboratory and in animal studies. The experimental treatments with the most promising laboratory results (in vitro and animals) are moved into clinical trials. In clinical trials more information is gathered on experimental treatment, its risks and how well it may or may not work.

2) Why participate in a clinical trial?
By enrolling themselves participants in clinical trials can play a vital role in their own health care, can gain access to new research treatments before being widely available, and help contribute towards betterment of society and to medical research as a whole.

3) Is it safer than regular treatment?
The scientific and ethical conduct followed in medical practice also applies to clinical trials. Going a step ahead, most clinical research is well regulated with built in safeguards to protect the rights, safety and well-being of participants. Individual participants’ names remain secret and are not be mentioned in any reports. Continue reading

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Roles and Responsibilities of CDSCO:

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Many of us of in India, have heard about CDSCO and have got confused about its role and relation with DCGI. So what is CDSCO? CDSCO stands for Central Drugs Standard Control Organization. CDSCO is a licensing authority, a regulatory agency which approves any new chemical entity (drug) which is to be imported to India.

Authority: Who is Who?

CDSCO is controlled and governed by Directorate General of Health Services which comes under ministry of health and family welfare, Government of India. The headquarter  of the Central Drugs Standard Control Organization is located at New Delhi, while it has multiple zonal offices throughout India. CDSCO also works in close context with Central Drug Laboratories to perform quality control tests. Continue reading

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