Phase 0 and Phase 1 Services to be completely outsourced to Asia by 2011
The Asian Clinical Trials industry is being expected to be around $1.5 billion in 2008 and is all ready to double itself in size by 2012. The huge share of Clinical Trials industry in Asia will be held by India, China and Russia. Many other Asian countries that are very firstly developing the most required technical expertise and resources skills necessary to cater to the growing global trend of outsourcing clinical research are Taiwan, Hongkong and South Korea.
Asia is the fastest growing outsourced clinical research destination in the Globe; with the clinical research market in Asia estimated to double in size by 2012.Asia’s big advantage remains the availability of large numbers of well-qualified personnel. The cost benefits of conducting a clinical trial in Asia are well proven by the whopping 50 percent savings in conducting phase I, and nearly 60 percent savings in conducting phase II & III trials in Asia.
This growth is further augmented by the rapid advances made in the improvement of medical infrastructure in Asia.Local corporate hospitals like the Apollo group are expanding their presence in various parts of Asia and are adding several different types of specialties to each center. Also, International hospital chains like Columbia-Asia have entered Asia and are all set to scale-up the medical infrastructure in Asia to International levels.
These changes have increased the confidence of global pharmaceutical companies in Asia being able to provide quality CRO services.Benefits such as diversity, availability of patients, availability of medical, scientific and laboratory resources, educational qualification, cost-effective labor and infrastructure, availability of resources, growing compliance on quality and regulatory standards, intellectual capital, services conscious culture, host of major outsourcing services platforms, fastest growing continent, and climatic condition.
Surveys and studies for the last year reveal that India has been the most preferred clinical destination in Asia. Last year India has bagged around 139 clinical studies outsourced to it, on the other hand china could bag only 98 studies, clearly showing the growth in India’s stature in Asia as the most preferred clinical destination. ClinAsia is completely leveraging on this Asia Advantage. This is the hot topic now and many international CRO’s are looking to increase their operations in Asian region.
One other study says that India is all set to capture 15% of the world’s clinical studies market by 2011 and all initial studies phase 0 and phase 1 would be outsourced to India completely. ClinAsia is one among few to have realized this potential at the earliest and planned its services on the similar trend second to none.
www.clinasia.com
Friday, February 6, 2009
Thursday, February 5, 2009
CDISC Services
CDISC Services
CDISC is the most significant development for convenience in data exchange without confusion within the pharmaceutical industry and between the industry and regulatory authorities. After being recommended by FDA, this data standard has been implemented by clinical research organizations, contract research organizations, Pharma/biotechnology companies, and other companies which use or generate clinical data. CDISC standards are employed as a service by many organizations as it brings clarity and simplicity to the clinical data which is now far more organized than before after CDISC standards implementation.
CDISC standards have a direct and strong impact on the clinical development process. CDISC standards define the data structures within the clinical database management system, case report tabulations and analysis datasets. These standards affect several operative functions where clinical data has to be handled or is handled.
ClinAsia has a very deep understanding of CDISC standards and services and believes these help in achieving the miracles in driving the Clinical Research process. Hence provides a number of services on the lines of CDISC.
www.clinasia.com
CDISC is the most significant development for convenience in data exchange without confusion within the pharmaceutical industry and between the industry and regulatory authorities. After being recommended by FDA, this data standard has been implemented by clinical research organizations, contract research organizations, Pharma/biotechnology companies, and other companies which use or generate clinical data. CDISC standards are employed as a service by many organizations as it brings clarity and simplicity to the clinical data which is now far more organized than before after CDISC standards implementation.
CDISC standards have a direct and strong impact on the clinical development process. CDISC standards define the data structures within the clinical database management system, case report tabulations and analysis datasets. These standards affect several operative functions where clinical data has to be handled or is handled.
ClinAsia has a very deep understanding of CDISC standards and services and believes these help in achieving the miracles in driving the Clinical Research process. Hence provides a number of services on the lines of CDISC.
www.clinasia.com
Wednesday, February 4, 2009
Careers in Clinical Trials
Careers in Clinical Trials
Every human on the basis of his interests, passions and opportunities available define their careers which they strive to make it successful and useful to the society. There has been a series of promises in and around the career of a person or a team. Each career has a different set of characteristics associated with it. Some career call in for high amount of patience and few others call in absolute alertness while some others call for the on the move profession.
A career in clinical trials is something which has been termed to be very special. It is termed to be special as it does not call for any special characteristic; rather it calls for a combination of characteristics as the people opting for this career are always accurate and appropriate in all disciplines.
Experts in Clinical trials industry are responsible for the activity with in their own area of specialization and are made accountable for those activities. An expert always needs to be at his best as his activity is the source for some other activity with in clinical trials. Hence a small error by anyone in the entire process may show an adverse effect on the entire process of Clinical Trials.
Hence a career in Clinical Trials calls in for a huge commitment and the highest level of professionalism and accuracy. The entire concept of Clinical trials is mostly concerned about Quality and Efficacy. This is the gateway of success for clinical trials. Given such high standards, the industry at present is facing a shortage of experts.
Sighting this shortage of experts, globally many educational institutes have come up in numbers offering expert courses and suggestions to make interested students as the assets of this industry for the future. However the students who come from such institutes with good theoretical knowledge needs to be trained properly with industry expertise to make them fit the industry standards and requirements
Many Clinical Research Organizations like ClinAsia offers excellent training in this regard to fill in the gap from college to corporate. This training provides excellent opportunities for people to fit directly into the industry standards and requirements.
ClinAsia possess a huge availability of experts and associates related to various therapeutic areas and various designations in the clinical trials process. ClinAsia can also help the most in patient recruiting and other related activities.
www.clinasia.com
Every human on the basis of his interests, passions and opportunities available define their careers which they strive to make it successful and useful to the society. There has been a series of promises in and around the career of a person or a team. Each career has a different set of characteristics associated with it. Some career call in for high amount of patience and few others call in absolute alertness while some others call for the on the move profession.
A career in clinical trials is something which has been termed to be very special. It is termed to be special as it does not call for any special characteristic; rather it calls for a combination of characteristics as the people opting for this career are always accurate and appropriate in all disciplines.
Experts in Clinical trials industry are responsible for the activity with in their own area of specialization and are made accountable for those activities. An expert always needs to be at his best as his activity is the source for some other activity with in clinical trials. Hence a small error by anyone in the entire process may show an adverse effect on the entire process of Clinical Trials.
Hence a career in Clinical Trials calls in for a huge commitment and the highest level of professionalism and accuracy. The entire concept of Clinical trials is mostly concerned about Quality and Efficacy. This is the gateway of success for clinical trials. Given such high standards, the industry at present is facing a shortage of experts.
Sighting this shortage of experts, globally many educational institutes have come up in numbers offering expert courses and suggestions to make interested students as the assets of this industry for the future. However the students who come from such institutes with good theoretical knowledge needs to be trained properly with industry expertise to make them fit the industry standards and requirements
Many Clinical Research Organizations like ClinAsia offers excellent training in this regard to fill in the gap from college to corporate. This training provides excellent opportunities for people to fit directly into the industry standards and requirements.
ClinAsia possess a huge availability of experts and associates related to various therapeutic areas and various designations in the clinical trials process. ClinAsia can also help the most in patient recruiting and other related activities.
www.clinasia.com
Tuesday, February 3, 2009
Recession - Impact on Clinical Trials
Recession – Impact on Clinical Trials
Recession is the word gaining prominence across the globe slowly but steadily, there by passing an underlying message of the seriousness of the issue to be more severe as the days pass in the calendar year of 2009. Recession which has shown its signs in the mid 2008 has taken its toll particularly on the Information Technology sector and other sectors.
The signs of recession to the common man are non availability of liquidated funds, job threat and rise in prices of essential commodities. Hence amid such a commotion all over the world to meet the challenge of recession, the thought in the minds of an expert related to Medical, Pharma and drugs would feel is that did recession really impact on the Pharma and life sciences industry particularly Clinical Trials.
Recession does have some impact on the Clinical Trials indirectly. Clinical Trials process today is by and large dependent on many other factors such as technology, ware housing and logistics so on. Hence a global slowdown may have its impact on clinical trials which is of the opinion that it is manageable for the current situation
Recession may also have some impact on the clinical trials which are now being planned, but the trials which have been planned earlier must be having their funds intact necessary to run clinical trials already planned. The dry nature of liquidated funds may possess some concerns for the Clinical Trials Industry.
However Pharma industry also has shown some signs with the layoff from Big Pharma recently. Though there is some sort of assurance for the current situation, however if the situation takes a severe form in the future, we need to keep our fingers crossed. The only way which appears for now to meet this situation is to stay planned.
I leave the conclusion on this article for debate and discussion on the thoughts and impact of recession on Pharma industry particularly clinical trials…
www.clinasia.com
Recession is the word gaining prominence across the globe slowly but steadily, there by passing an underlying message of the seriousness of the issue to be more severe as the days pass in the calendar year of 2009. Recession which has shown its signs in the mid 2008 has taken its toll particularly on the Information Technology sector and other sectors.
The signs of recession to the common man are non availability of liquidated funds, job threat and rise in prices of essential commodities. Hence amid such a commotion all over the world to meet the challenge of recession, the thought in the minds of an expert related to Medical, Pharma and drugs would feel is that did recession really impact on the Pharma and life sciences industry particularly Clinical Trials.
Recession does have some impact on the Clinical Trials indirectly. Clinical Trials process today is by and large dependent on many other factors such as technology, ware housing and logistics so on. Hence a global slowdown may have its impact on clinical trials which is of the opinion that it is manageable for the current situation
Recession may also have some impact on the clinical trials which are now being planned, but the trials which have been planned earlier must be having their funds intact necessary to run clinical trials already planned. The dry nature of liquidated funds may possess some concerns for the Clinical Trials Industry.
However Pharma industry also has shown some signs with the layoff from Big Pharma recently. Though there is some sort of assurance for the current situation, however if the situation takes a severe form in the future, we need to keep our fingers crossed. The only way which appears for now to meet this situation is to stay planned.
I leave the conclusion on this article for debate and discussion on the thoughts and impact of recession on Pharma industry particularly clinical trials…
www.clinasia.com
Monday, February 2, 2009
Clinical Trials - History
Clinical Trials – History
Clinical Trials is believed to be a practice that concerns to construct human life and is a never ending investigation aimed at finding out the best possible drug to win over the disease of abnormality in a human being. Clinical Trials is not a new term to be heard off. This practice was in existence from times in memory and shall be in practice for times to come. It’s a long journey witnessing success, pains, and transformation.
Clinical Trials history dates back to 605-562 BC….
605-562 BC
Unknowing that this practice of his would be called a clinical trial in future King Nebuchadnezzar II carried out the first ever clinical trial when he ordered that a strict diet of meat and wine be followed for three years by his people. However, four children of royal blood convince Nebuchadnezzar to allow them to exchange bread and water for the required meal due to their personal reasons. Their plea was accepted that they should have only bread and water. After only ten days it was noticed, those who have switched to bread and water appear healthier and well nourished than those who have stuck to wine and meat.
1537
Renaissance surgeon Ambroise Parè accidentally mixes a concentration of oil of rose, turpentine and egg yolk as a replacement for the regular oil medication for treating open wounds.
1600
A group of nomads heading towards East Indies through dense forests and sea routes as a part of their meal added sour oranges and lemon help them improve their health and fitness required to wander far off lands.
1747
First ever controlled clinical trial recognized was conducted by James Lind in which he succeeded in proving the medical behavior of lemon juice.
19th Century
Clinical Trials with the concept of Placebo emerge. This brings in a system of conducting clinical trials with the need of emergence of regulatory authorities.
20th Century
A shift from paper based complex clinical trials towards a simplified electronic reliable systems to count down on time and cost and there by rocketing productivity.
ClinAsia can fill in as a bridge in this transition and help its clients to bring out the miracles of medicine to the mankind…
http://www.clinasia.com/
Clinical Trials is believed to be a practice that concerns to construct human life and is a never ending investigation aimed at finding out the best possible drug to win over the disease of abnormality in a human being. Clinical Trials is not a new term to be heard off. This practice was in existence from times in memory and shall be in practice for times to come. It’s a long journey witnessing success, pains, and transformation.
Clinical Trials history dates back to 605-562 BC….
605-562 BC
Unknowing that this practice of his would be called a clinical trial in future King Nebuchadnezzar II carried out the first ever clinical trial when he ordered that a strict diet of meat and wine be followed for three years by his people. However, four children of royal blood convince Nebuchadnezzar to allow them to exchange bread and water for the required meal due to their personal reasons. Their plea was accepted that they should have only bread and water. After only ten days it was noticed, those who have switched to bread and water appear healthier and well nourished than those who have stuck to wine and meat.
1537
Renaissance surgeon Ambroise Parè accidentally mixes a concentration of oil of rose, turpentine and egg yolk as a replacement for the regular oil medication for treating open wounds.
1600
A group of nomads heading towards East Indies through dense forests and sea routes as a part of their meal added sour oranges and lemon help them improve their health and fitness required to wander far off lands.
1747
First ever controlled clinical trial recognized was conducted by James Lind in which he succeeded in proving the medical behavior of lemon juice.
19th Century
Clinical Trials with the concept of Placebo emerge. This brings in a system of conducting clinical trials with the need of emergence of regulatory authorities.
20th Century
A shift from paper based complex clinical trials towards a simplified electronic reliable systems to count down on time and cost and there by rocketing productivity.
ClinAsia can fill in as a bridge in this transition and help its clients to bring out the miracles of medicine to the mankind…
http://www.clinasia.com/
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