ClinAsia

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.

http://www.clinasia.com/

Phase IV Services

ClinAsia clinical experience in product development ensures collaboration and integration from pre-approval to post-approval. We provide a custom-tailored process, fine-tuned across the globe, to meet local regulatory requirements. Our operational model is based on a robust technology platform to support remote centralized management of our clients' sites, and our operating procedures are designed for a post-approval setting.

Early Post-Approval Planning

ClinAsia team helps its client in post approval planning in manufacturing and go to market strategies.

Product Safety and Pharmacovigilance

The team has extensive experience in the collection of safety information for more than 100 products, covering a broad spectrum of therapeutic areas.

Late Stage Research Services

ClinAsia team has helped clients develop and implement late-stage research, including registries and observational studies for more than 10 years.

Registries and Observational Studies

ClinAsia can help in maintaining registries and conduct observational studies once the product has been approved.

www.clinasia.com

Phase II-IIIb Services

We at ClinAsia advance a product through development and approval on time and within a client's budget. Our experienced teams deliver quality results for our clients' drug development needs.Development ConsultingOur strategic product development solutions offer our clients the best long-term strategies for their products.

We help our clients reach key milestones in a timely and cost-effective way while minimizing risks by designing, planning and implementing high quality, strategic product development programs.

Data Management

ClinAsia provides data management expertise and comprehensive data management services for Phase I-IV clinical trials. The data management planning process emphasizes close communication with the sponsor through all phases of development and review of database specifications.

Quality Assurance

ClinAsia staff is accessible and responsive to questions and requests for information during any part of a study. We provide an independent assessment of the client's quality assurance procedures, based on Good Clinical Practices, regulatory requirements in drug development projects.

Project Management

Our project team ensures deliverables on-time and on-cost, resulting in effective Phase programs. Your people will be fully trained in the therapeutic area being studied and possess a remarkable ability to anticipate risks and finish of the study on a clearly visible success note.

Clinical Monitoring

As always our clinical monitoring teams deliver quality, timely results. Counting by therapeutic industry experience with which ClinAsia provides consistent, effective and interactive dialogue at the sites.

Safety and Pharmacovigilance

Through our customized safety plan we provide comprehensive safety coverage round the clock. We ensure safety by maintaining clinical safety databases, effective monitoring through coordination of data monitoring committees and also using effective alerting system which is automated with a signal alarming system.

Patient Recruitment

Effectively designed programs help ensure that ClinAsia will generate the calls needed to meet your enrollment targets.

Biostatistics

We provide biostatistics consultation, programming, and analyses. Software used includes SAS, StatXact, nQuery Advisor, and other cutting-edge products.

Regulatory Affairs

ClinAsia ’s regulatory affairs staff provides flexible and responsive services according to your needs, ClinAsia regulatory affairs team assists you in meetings with regulatory authorities provide scientific advice and define a regulatory strategy.

www.clinasia.com

Phase 1 Services

ClinAsia Phase I services is treated as one of the best in the world with the proven ability to carry out multiple studies in parallel, and our services span over from healthy volunteer clinics to regulatory affairs. ClinAsia ability to successfully facilitate large trials along with our committed, experienced experts enables effective planning strategy and implementation for the first phase of clinical trials.

Research Clinic

Created specially to enhance first-phase trials, ClinAsia research clinic has a huge range of specialized technology facility for storing and handling, administering and monitoring new drugs being planned for development. Taking into account the clinical expertise ClinAsia possess ClinAsia deals with the studies such as First Administration into human, Bioequivalence, Bioavailability, Ascending dose safety, Drug interaction at macro level.

Clinical Monitoring

ClinAsia expert trained Associates ensure the ultimate quality review of data and improved interaction with study sites. ClinAsia clinical research associates during their monitoring makes sure to see over data collection, view source documentation, case report forms, regulatory compliance, solve data queries and implement interim analyses.

Project management

ClinAsia from its vast experience in the past learns that project manager is the captain made responsible for the successful functioning of a trial and it’s his responsibility to ensure that the project is on time and on budget. ClinAsia assigns one of our super senior experts and shall be made a point of responsibility as well as a point of contact for all future interactions till the close of the study.

Data Management

ClinAsia provides data management expertise and comprehensive data management services for all phases of clinical trials. The data management planning process symbolizes regular communication with the sponsor through every phase of development and review database specifications. Quality control mechanisms monitor every element of the data management process, and ClinAsia helps minimize the client’s technology investment through guidance in the most effective use of appropriate technology according to the sponsor’s particular needs and preferences.

Biostatistics

ClinAsia provides biostatistician consultation, analyses and programming. Software which would be for this purpose includes SAS, StatXact, nQuery Advisor, and other leading marketing edge products.

Pharmacovigilance

Through ClinAsia customizable safety plan we provide efficient safety coverage round the clock. ClinAsia ensures safety by effective monitoring through coordination of data monitoring committees, maintaining clinical safety databases and also using innovative alerting system which is automated with a alarming system.

Regulatory Services

ClinAsia ’s regulatory affairs staff provides flexible and responsive services according to your needs, ClinAsia regulatory affairs team assists you in meetings with regulatory authorities provide scientific advice and define a regulatory strategy

http://www.clinasia.com/

Therapeutics

When you think outsource your drug development clinical project, you think of the one who can stand up for you and deliver. At ClinAsia it is ensured that you shall feel us as an extension of your own team.

Our task on hand is to drill down in to our expert resources and ensure driving your project successfully on time with a value addition. Superior solutions, proactive service and a personal approach are the trademarks of ClinAsia which makes it as the most preferred partner to many clients in Asia and globally.

It is most important and necessary that you work with a clinical research organization that has highly organized expertise in clinical development and has the most critical clinical and therapeutic expertise to meet your requirements and expectations. At ClinAsia we have a significant range of local and global therapeutic expertise, and in many therapeutic areas ClinAsia knowledge is second to none.

ClinAsia specializes in the following Therapeutic areas:

• Cardiovascular
• Oncology
• Central Nervous System
• Dermatology
• Immunology
• Hermatology
• Opthalmology
• Pediatrics
• Urology
• Respiratory
• General Medicine
  
  

PreClincal Services

PreClinical Services

ClinAsia daily schedule consists of developing programs to provide correct information about the chemical making of a new drug, its safety, its formulation strategy and its administration procedure to be followed when provided to the first man.

Using past data about the chemical making, we help our customers create an effective regulatory strategy formulation for good laboratory practice, toxicology and metabolism clinical studies required to support first-human studies.

Non-Clinical Development Program

Previously made development programs to avoid early chemical complexities in Clinical Trials.

Preclinical Estimation

Our experts at ClinAsia provide a complete range of research services to clients to select the most suitable study design and additional screening method for an investigational agent and there by maintaining the Preclinical estimation.

Chemistry, Manufacturing and Controls Consulting

Taking into account our customers manufacturing facilities, ClinAsia provides regulatory guidance to suit specifications, method creation and validation as well as co-coordinating stability studies.

Pharmacology and Toxicology

ClinAsia has extensive expertise in pharmacology with preclinical efficiency, efficacy, General Toxicology, Special Toxicology, Genetic Toxicology, reproductive and development toxicology, Safety pharmacology to guide clients through the preclinical phase.

Regulatory Submissions

ClinAsia has extensive experience preparing all major regulatory submissions, including complex multinational submissions for any type of drug applications.

www.clinasia.com

Clinical Data Integration

Data integration, known in the pharmaceutical world as ISS (Integrated Summary of Safety)and ISE (Integrated Summary of Efficacy), is a multi- latitudinal task, and is well recognized for its tediousness and time-consumption. Therefore, it is desirable to automate such a time-consuming task so that a routine process can be developed. Is this wish realistic or achievable to a certain degree?

Research data usually come from multiple sources. An epidemiology study may use historical controls from different time periods and geographic locations in a case-control study. A health economist may want to combine physician data from the AMA database with those of a company’s database.

In a typical clinical study, data may come from different trial sites, especially from international sites, from different labs, or from parallel protocols.Furthermore, for the convenience of analysis, statistical analysts in a multi-protocol study may create their own derived variables or flags for their own individual protocol, which are usually not communicable to each other across protocols

This system tries Data from different sources are rarely the same. In many circumstances, therefore, data integration is an essential step fo r standardized, consistent, and homogeneous reporting. Integration is in fact the process that uniforms different data sets so that they can be pooled together. Because the process is typically done manually, it is tedious, time-consuming, and can easily frustrate or overwhelm the most experienced programmers by the detailed attention and the large amount of home work.

Is there anything that can be done to reduce such a workload? Being aware of a lack of sucha technical tool for data integration in the industry, Kindly share your inputs in regards to this.

www.clinasia.com

ISS/ISE Standardization

ClinAsia is highly interested and most considered about the safety and efficacy of the drug under study and is in compliance with CDISC ISS/ISE studies standardization and has proven its services in this area through its strong expertise and experience in this area.

Services include:

• Analysis Plans to enhance Integrated Summaries of Safety and Efficacy
• Integrated Efficacy and Safe Datasets
• Integration of data sets to any format
• Acceptance Coding across studies
• Data Integration Plan
• Integrated analysis, reporting Safety and Efficacy of Data
• Patient Profiles
• Case Report Tabulation Data Definition Specification

Clinical Trials - Collective effort to redefine Recession

Clinical Trials – Collective effort to redefine recession

Clinical Trials is basically a huge process accompanies by a set of procedures which needs to be followed with utmost precise and perfection. The basic nature of clinical investigations is cost and time involved. This is always a challenge that Clinical Research companies and sponsors face. However due to efficient clinical budgeting, planning and protocol preparation complex situations are avoided.

In the time when everything goes wrong across the globe, in an era that has stamped its impact on every sector across the world, an industry particularly the clinical trials or clinical research industry which is also dependant on many other parameters faces severe pressure. The great old theory of Darwin “Survival of the fittest” comes into play during the tough times.

Though recession has shown signs of frustration among the industry segments, clinical trials industry with its strong foundation and basics never showed any symbols of panic, however with the situation of recession going from bad to worst and with the big research companies predicting the actual worse is yet to come, Are clinical trials industry and companies globally ready to face it? What surviving strategies do the companies need to adopt. This requires a huge collective effort globally to fight it.

The news this hour that Charles River Laboratories reducing the workforce by 3% rings in the bells for others as well. Let’s initiate this collective effort to survive recession and be ready for the good days ahead. Lets join together to redefine the clinical trials destiny by sharing the experiences and strategies to fight recession.

www.clinasia.com

Clinical Trials in India

Clinical Trials in India

A vast, unwieldy population, a plethora of diseases, and rampant poverty: this was the picture India presented to the outside world till a while ago. Yet these days the fact that India has the largest pool of patients suffering from cancer, diabetes and other maladies is leading the country to an altogether different destination: the global hub of outsourcing of clinical trials.

Almost all the top names in the pharmaceutical world have zeroed-in on India, setting up clinical trail facilities in major cities, especially Hydearbad and Ahmedabad. Global consultancy McKinsey & Co estimates that by 2010, global pharma majors would spend around $1-1.5 billion just for drug trials in the country.

For instance, trials for a standard drug in the United States can cost about $150 million. A similar drug could be tested in India at a 60 per cent reduction of that whopping cost. India's drug industry officials say the clinical-trials outsourcing has just begun in the country. Here is the list of some gaints operating in India and finding it successful

Eli Lilly

The global pharmaceutical giant has 17 large and small clinical research projects running in 40 hospitals across India.

The company's clinical trials are to test if Xigris, which is indicated for reduction of mortality in adult patients, can be used for sepsis. Eli Lilly has already held clinical trials involving more than 600 patients for Human Insulin and Insulin Lispro. It is also these days conducting trials on oncology, and developing a new molecule for lung cancer.

Pfizer

The pharma giant has picked up six cities in the northeastern states of India to conduct clinical trials on 300 patients on a new malaria 'cocktail' drug that combines chloroquine (to which Indian malarial strains have developed resistance) and azithromycin, an antibiotic.

Pfizer is also carrying out clinical trials for drugs to treat osteoporosis, breast cancer and schizophrenia. Pfizer's cumulative investment on clinical research in India is believed to be $13 million.

Roche

The Swiss pharma major has set up clinical trial sites in India as part of its global trials for treatment of a particular variant of lung cancer. One of the reasons for considering India is that it has a vast patient population infected by this type of lung cancer, which is primarily triggered by use of tobacco products.

India is also being considered a prospective site for Roche's future clinical trials involving new drugs and therapies for treatment of different variants of blood cancer and colorectal diseases.

SIRO Clinpharm

SIRO is currently conducting clinical trial projects in over 30 hospitals across the country for several clients from Europe, Japan, the United States and also India. The trials in India are mostly in different areas like oncology, endocrinology, traumatology, sports medicine, pulmonary diseases, pediatric diseases and infectious diseases.

Clinigene International

The Bangalore-based Clinigene says India's huge population allows new-drug studies to be completed much faster. Last year, when a biotechnology company from the US needed 400 diabetics for a study, Clinigene began by heading to a nearby hospital specialising in diabetes, where a dozen new patients arrive every day and more than 40,000 are in its records.

ClinAsia believes Indian market would flourish to a great extent and is ever ready for opportunities bieng a clinical research organization with excellent infrastructure second to none.

http://www.clinasia.com/

Clinical Trials - Future Trends

Clinical Trials - Future Trends

Clinical Trials have been gaining prominence off late. Often Clinical Trials procedures and processes are assumed to be complex due to the structure in practice. However there have been lot of speculation pertaining to these procedures and processes related to clinical trials. This introspection has began along with the time and change in the levels of technology. The detailed level of existing procedures create a complex environment due to its huge way of performing things which calls for the best accuracy and concentration to handle things.

To maintain this accuracy and concentration, a clinical trial needs to depend on huge number of people in the paper based environment. The manual process was always time taking and costly. This confusion as the technology has evolved started having a glimpse to make use of technology and automate certain process which would take time and also would be cost effective. This technology has the capability to keep itself intact the most required accuracy, quality and efficacy.

The regulatory authorities noticing this trend in clinical trials have come out with few guidelines for the usage of software in clinical trials like EDC for data capture, SAS for Analytics and Reporting, eCTD for common standard of submissions and more in compliance with 21 CFR Part 11, CDISC standards, HL7, ICH guidelines.

Today many organizations associated with clincal trials are making use of these softwares available from good vendors. These softwares help us in automating the part of the process related to clinical trials and helps us in saving time and cost, preserving accuracy. This is the situation of change that clinical trials over the years have witnessed.

For Clinical trials now and in future.....whats next!!! whats in store!!! whats the road ahead????

Please contribute your thoughts in terms of the future trends of clinical trials with respect to procedures, process, softwares, Regulatory and all other related issues....

http://www.clinasia.com/

Clinical Crown 2009

Clinical Crown 2009

Clinical Crown 2009 is an interesting and innovative game for the mutual benifit of the clinical trials, life sciences and pharma communities...Clinical Crown 2009 promises you fun,entertainment, learning and gears you up for your day to day activities. Lets join collectively for this cause.

Clinical Crown 2009 is aimed at mutual benifit of all. We invite experts, students and other interested people to participate. At the end of the game it is guaranteed that we all shall have at our hand a collectively compile information which shall be useful for all. ClinAsia kindly requests your support and few minutes of your time towards achieving this.

Everyone is invited to participate in this and the following is the simple procedure to participate in Clinical Crown 2009...

Rules:

• Select the most appropriate nick name for yourself by posting your team name as a comment to this article. The name should be catchy and would be great if a name is related to pharma but not mandatory. Further you would be recognized by this name only.
• The next set of rules for the game would be revealed on coming Monday. Hence till Monday team names can be registered.

Thanks in advance for the extended support...

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.

At ClinAsia the first step in the CDISC mapping specification document service employs the comparison of the study metadata on par with the SDTM domain metadata. In complex studies where the CDM metadata was most suitable to the maximum extent possible with SDTM metadata, it is recommended to make use of automated mapping as a first step. Then If CDISC standard data sets and variable names were properly arranged in the CDM data sets, it is more suggested to use a data step or SQL select to verify for direct matches and document then so that the validity of the mappings can be mapped. This procedure only serves as a first step of SDTM metadata mapping, but it can purposefully eliminate hours of manual mapping. If the CDM metadata is not mapping with the SDTM metadata or if SDTM specifications were improperly used, then auto mapping is suggested to be avoided as the best choice

The successive step at ClinAsia in this service area employs manual mapping of the study data sets to the actual domain data sets and then there by mapping each single variable to the appropriate domain. Varying on how the CDM data is structured, you may have a facility to map each CDM file to every suitable single domain, and ensure a split its variables among multiple domains, or a combination of variables from multiple CDM files into a single existing domain. There are many types of variable mapping possible.

www.clinasia.com

Phase 0 and phase 1 clinical studies to be completely outsourced to India by 2011

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

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

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

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

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/

Asia Advantage for Clinical Trials

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.