Monthly Archives: August 2009

The regulatory laws in major Asian countries donot permit the early phase trials on account of the high risk involved. Most of the early phase drug development is considered un ethical in the Asian countries if carried out without regulatory permissions. Hence the market growth in Asian countries tends to take a backseat on account of the same.
Most of the early clinical development takes place in the developed markets of the USA and Europe. The Early Phase trials which are then conducted are then projected and conducted in relevant populations and geographical regions (As per protocol, sponsor and regulatory requirements and the results, i. e. endpoints of the trial. Thus most of the outsourced clinical development market comes to the cost effective Asian regions only in the post early phases i.e. phase II onwards.

Veeda Clinical Research is a leading Indian CRO which caters to cost effective bio-equivalence studies for the Global and Indian Pharma industry and early phase development in United Kingdom in a major way.

Branded drug sales have been the key revenue driver for the Big Pharma. As the data exclusivity period has reached an expiration period for big pharma and generic drugs and copy cap manufacturers capture the share of the branded drug sales, pharma companies are left with few options of maintaining their profitability on an on going basis. The Pharma spend millions of dollars as their allocated budgets in lobbying for sustaining their branded drug sales.

The “Monopoly ” phenomenon takes its shape actively when the Global pharma places its presence in the emerging markets of Asian countries like India for establishing a Generic drug presence and fuel their growths. These approaches have given a Big Pharma MNC an “edge”” in their monopolies.

Veeda Clinical Research is an Indian CRO which provides cost effective Bio-Equivalence studies for the drug industry.

The Indian Pharma industry is being faced with a debate over the exports of Generic products. There has been lobbying over the same among local manufacturers and the larger players in the IPM for capturing the share on the same. It seems that this debate/ conflict has arisen because of the fact that the generics form the local manufacturers need to be promoted to the regulated markets on a larger scale.
Hopefully the debate and issues related to the same would take a backseat and Indian pharma export growth would surge despite all odds.
Veeda Clinical Research is a leading Indian CRO which caters to cost effective bio-equivalence studies for the Global and Indian Pharma industry in a major way.

The drug regulators of various countries believe in maintaining a uniform code of compliance as far as possible across their regulatory framework and in the companies where they conduct audit for measuring and ensuring compliance. No stone is left unturned while examining the records of the companies under the regulatory scanner.
Compliance or adherence to the available regulatory framework is the need of the hour. As compliance issues become mandatory and acquire a more complex dimension, procedures and paths to achieving the same become longer and complicated as well. This is true for both Pharma manufacturing companies as well as CRO’s.
There arises a need to raise perfection standards within companies to ensure compliance with external auditors. This process is not a ONE day affair but an ongoing and routine procedure which needs to be achieved with appropriate monitoring and caution by internal company auditors.
Veeda Clinical Research is an Indian CRO which provides cost effective Bio-Equivalence studies for the drug industry .

Knowledge of the known is relative phenomenon. Knowledge of the existing unknown is a discovery. The extent of discovery is nothing but development of scientific facts and scientific facts lead to creation of expertise and understanding of the subject under contention. Hence, virtually over a period of time the “unknown “”becomes known. The time period of approaching the unknown is highly variable. The Known is always”” competitive”” and the unknown is sometimes a treat or an opportunity.

Similar is the case with the drug industry. The drug industry has 2 avenues for investment, one is the known i.e. Generics and the unknown which is clinical development. Both the avenues are open to the CRO industry as well. The Generic drugs when tested in human beings have a known response to the drugs whereas the drug response of drugs in clinical development is unknown. Companies have to accordingly devise business strategies to sustain their grow in the short and long term
Veeda Clinical Research is an Indian CRO which provides cost effective Bio-Equivalence studies for the drug industry.

As the trends in the world move towards “”recovery”” or a possible recovery, service based industries like CRO’s which are “”reliant”” on the Pharma and the biotech sector in a major way need to plan strategies which are “realistic”, take into account aspects, issues and approaches which are long term and cover the risk aspects for the future as a blanket coverage.

The teams associated with the designing of the strategic aspects of their respective companies need to understand and align the vision and the goals together which can then prove as “”Bulls “Eye for the CRO Growth.
For a CRO business, timelines related to lab analysis and project management are critical in all respects. These need to be addressed in manner where operational matter related to procedures in coordination, client communication, study updates and relevant matters may decide the “fate ” for the start of the study in a unit and its subsequent execution and completion/ submission of the final report. At every step along with the expertise of the experienced, a realistic approach has to be exercised at every point. The steps that need to be taken have to rational and defined so that the end result is accurate, defined and in the well defined timelines.

Veeda Clinical Research is an Indian CRO which provides cost effective Bio-Equivalence studies for the drug industry

“The demand for CRO services has been and is predicted to rise in the times to come. The same is driven mainly by the Outsourcing budgets of the Pharma industry which “”tend”” to be variable as the market conditions takes upward and downward swings with the times. Looking at the changing scenario of the market and its dynamics, the CRO’s would have to keep a watchful eye on the changing times, competitor activity in the markets, placing their KYC appropriately, budgeting their studies in line with the sponsor expectations and look towards an optimistic forecast in the times to come.
As the demand for CRO services has taken a “”twist”” towards cost effectiveness, minimizing overheads and maximizing productivity, competition would be stiff and business goals would be requiring mammoth efforts for their achievement.
Veeda Clinical Research is an Indian CRO which provides cost effective Bio-Equivalence studies for the drug industry. ”

“The Indian Pharmaceutical industry is predicted to hold the potential in driving the Global drug industry in a major way.
The news and happenings in the key newspapers talk of the same in a major way. Looking at the scene of the Global Pharma industry today which speaks of the “”lacunae in the strategist bag of ideas””, the most potential and emerging market today is India. The Indian market with its size spanning the growth paths of the world domain go the extent of driving the market growths in the times to come which indicates”” generic dominance”” in the recessed times.
The Indian Pharma market was perceived to be only a threat in the past and forecasted by research companies as a “”name sake”” contender in the past but would a “”fulcrum force”” to reckon with in times to come.
The pressures from the “”recessed”” economy are making the Global pharma companies and the economies take a re look at the Indian geography and its drug players which have and are slowly spreading their tentacles in the recent past.
Veeda Clinical Research is an Indian CRO which provides cost effective Bio-Equivalence studies for the drug industry.”

Business in all industries is associated with all a varying nature of grievances and problems. No business is risk free or easy to manage or live in especially in the current recessed times. The times of recession has forced companies to “Ignore” grievances’ and move ahead in all measures which relate to achievement of business goals and company policies. The Outsourcing industry is no exception to that rule and includes the CRO sector as well.
The CRO Industry has been predicted to be the sunrise industry in the last 4-5 years. Despite all other product and service based industries taking the aftermath of the prevailing slowdown, the CRO industry has continued to follow the pursuit of positive trends.

Going against the tide has been difficult for the CRO’s and the “”grievances’ “”are reflective in the quarterly results of the companies. Forecasting revenues for the remaining year has not been particularly “simple”for these companies.

Veeda Clinical Research is an Indian CRO which provides cost effective Bio-Equivalence studies for the drug industry.

Placebos are getting more “effective”. It sounds absurd but many “clinical studies “”in the world of clinical research have proved so. This explains the success and failure of new drugs in the clinical trials during the process of drug development.
The clinical trial endpoints in the process of drug development start from drug action and its toxicity in human beings to efficacy and finally efficacy and safety on a larger base of patients in the final or deciding phase of drug development (i.e. Phase III).
Benchmarking the drug performance in a human body in particular clinical trial phase is conducted by administration of “”blank sugar coated”” tablets to the subjects/ volunteers/patients in a particular phase of drug development. The “”higher “”is the number of the subjects/ volunteers/patients crossing the “”plasma Levels”” of the NCE with respect to the placebo, higher is the success of the clinical trial results. Optimum “”blood plasma”” levels are attainable when a substantial amount of dosage of drug when administered to the drug proves itself effective with respect to its efficacy in the desired number of patients with respect to the placebo. This is the major driving force for all listed companies in Pharma/ Biotech/ CRO’s to generate investor confidence and trigger their interests in investments for their clinical trials for the phase of interest.
Veeda Clinical Research is a leading Indian CRO which caters to cost effective bio-equivalence studies for the Global and Indian Pharma industry and early phase development in United Kingdom in a major way. ”