Importance of Clinical Data Management

Introduction:

Clinical data is one of the most valuable assets for a pharmaceutical company and these provide vital confirmation of a drug’s efficacy and safety. Massive amount of data is collected during the entire life cycle of clinical research. Data management serve as the basis for

• Collection
• Storage
• Validation
• Analysis
• Submission
• Approval
• Labelling
• Marketing of a compound

Clinical Trial data can come from a variety of sources:

• Investigator sites.
• Laboratories.
• Directly from subjects and partners.

Clinical data management (CDM) system plays a vital role in clinical trials to ensure high-quality data are captured effectively and ethically by sites staff through paper case report form (CRF) or electronic case report form (eCRF). Data collected through various phases right from the phase zero trials. These captured data are designed and made accessible for early review. Collected data will be utilized to characterize the subject/patient population and also to evaluate the safety and efficacy of drug. Structured databases are used to collect, organize and analyze clinical data. Sponsor is responsible for the integrity and quality of data and this could be ensured by collecting and transferring data from study subjects to a clinical data management system.

The sponsor of the drug will rely on this data to secure the marketing rights. However, even in the case of a clinical trial producing negative results, clinical data provides certain informational advantages to its holder for e.g.,Clinical trial results can be applied to make adjustments to other R&D projects in the same or a related therapy area and also assist in forecasting the probability of the R&D programme leading to a marketable product. A key condition for the subsistence of database rights is that there must have been ‘a qualitative or quantitative substantial investment in either the obtaining, verification or presentation of the contents of the database.

(CDMS) must be monitored, to ensure a reliable and effective base for

• New Drug application (NDA) Submission
• Clinical Science Reports
• Clinical Planning
• Decision-Making
• Process enhancement

According to the Data Warehousing Institute (DWI) estimates the cost of bad or ‘dirty' data exceeds $600 billion annually.

Cost per patient of Clinical StudiesThe cost per patient of clinical studies of new pharmaceuticals 

	Phases	Cost	No of patients involved
1	Phase 1	exceeds $26,000 per patients	20-80
2	Phase 2	$19,300 per patient	100-300
3	Phase 3	$15,700 per patient.	300-3000
	Total	$46,784,000 per average trial

If all the data collected during the clinical trial are invalid or unacceptable. How much would be the cost? Therefore, it is vital that CDM follows a systemic process and an established mechanism to avoid colossal loss in terms of finance and valuable resources. In order to prevent these irreparable mistakes, data collection and verification process will undergo validation at every stage. This will ensure that the data is clean, useful and consistent

Reason For erroneous data

Errors inevitably occur during data entry. Most common errors include:

• Typographical Errors
• Copying Errors
• Coding Errors

Prevention of erroneous data 
Prevention of erroneous data can be carried out through various set of established mechanism as below:
Edit checks and queries.
For example, it will not allow input of future date as "visit date", or enter any other gender then male or female etc.  
Data Entry tools
The effective use of data-capture tools ensures that high-quality data are available for early review and rapid decision-making 
Data clarification form should be maintained for clarification of queries that arises during discrepancy management

Trial monitoring is to verify

1. The rights and well-being of human subjects are protected
2. The reported trial data are accurate, complete and verifiable from source documents
3. The conduct of the trial is in compliance with the currently approved protocol/amendment(s), with GCP, and with applicable regulatory requirements.

Sponsor should ensure that trials are properly monitored. Part of monitor responsibilities, depending on sponsor request, is to verify data consistency with the source data or documents:

1. Dose or therapy modifications
2. Adverse events
3. Concomitant medications and/or intermittent illnesses
4. Visits, labs, examinations and tests required by protocol, but failed to perform.

All the above mentioned process can be done in an effective manner if we have Data management plan (DMP) in place.

Benefits of DMP:-
The work to be done and responsibilities are clearly stated at the start of the study so everyone knows what is expected.

The expected documents are listed at the start of the study so they can actually be produced during the course of rather than after, the conduct of the study.

Benefits of Data Validation
Missing data identification.
Handling missing data for data cleaning purposes must answer following questions:

• Was missing data collected on CRFs?
• Was missing data lost during data load or database manipulations?
• Was missing data loaded fully and correctly?

If all those questions are answered "Yes" then data cleaning job for missing data is completed.
Data reconciliation, which take place at the end of clinical trial and refers to a process that compares two sets of files to make sure they are in agreement
Queries that arise during the reconciliation of the data should be handled in the same manner in which clinical queries are handled Standard operating procedures (SOP) and quality analysis should be a part of every study

Conclusion:-But it is still a challenge for most of data managers and clinical team leads to distinguish "dirty data" from actual Protocol deviations. In fact, it is essential to have full, clean and accurate data to determine the Quality, safety and efficacy of the product.

References

www.dovepress.com/getfile.php?fileID=6592

http://www.ncbi.nlm.nih.gov/pmc/articles/PMC2656002/

http://jco.ascopubs.org/content/21/22/4145.full.pdf

Clinical Research Companies & Organizations – Careers in India

Clinical Research is the fastest growing sector of Health Care Industry and it is some of the most creative, forward-thinking in the business world. Clinical research is a part of Life science deals with the case study of safety and effectiveness of medications, instruments, diagnosis and products.

Clinical Research gives a wide range of cultural, educational and geographic backgrounds which helps your ability to work in a dynamic professional environment that values individual perspectives. There is a chance of huge career openings in this area, according to the British clinical research organization there is a need of 20lac clinical research professionals for the year 2015 globally.

To acquire the Best Research and Placement oriented Clinical Research program in Bangalore Avigna Clinical research institute is the leader which gives the great learning experience. In addition, ACRI placement cell will assist you the career opportunities. We have a wide and strong collaborations with the Leading MNC's and some are listed below.

Here we listed some of the Top MNC’s Clinical research Industries and their profiles::

 Semler Research Center              careers@semlerresearch.com
                                                       kavitha@semlerresearch.com

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 Indegene Lifesystems Pvt Ltd       info@indegene.com

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           Quintiles                           www.quintiles.com/careers/

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           Avigna Group                     careers@avignapharma.com

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Glorigin Lifesciences Pvt Ltd           info@glorigin.co.in

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 Cadila Pharmaceuticals                  careers@cadilapharma.co.in

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    Advinus Therapeutics Ltd.            info@advinus.com

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     APC Global                             APC Pharmaceuticals & Chemicals
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ARIANNE Clinical Research            info@ariannecorp.com
Organization ______________________________________________________________________________

        Aris Global                              careers@arisglobal.com         
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Columbia Asia Hospital                       kalappa.kb@columbiaasia.com
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KPS Clinical Services Pvt. Ltd            career@kpsclin.com
 ______________________________________________________________________________

 Lambda Therapeutic Research Ltd.    careers@lambda-cro.com
 ______________________________________________________________________________

           Max Neeman                      hr@neemanasia.com



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     © Avigna Clinical Research Institute , Bangalore  

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India CRO market to earn $1B by 2016, says Frost & Sullivan

The CRO market in India earned revenues of $485 million in 2010-11 and is estimated to cross $1.0 billion in 2016, according to new analysis from Frost & Sullivan, “Strategic Analysis of the Clinical Research Organization Market in India.”

The market is growing at a rate of 11%-13% as India builds its track record and gains increasing favor as a base for global clinical trials (phase I-IV). Participants operating in the Indian segment include multinational CROs that still dominate the nation's market, Indian CROs, multinational pharmaceutical companies and Indian pharmaceutical companies. While the first three categories of companies are into global trials, Indian pharmaceutical companies usually look at conducting local trials.

"Therapeutic areas in which research can be conducted in India are varied, and this is likely to result in more number of studies in the country," said Frost & Sullivan research analyst. "Emerging areas, such as diagnostic research, are also expected to drive the India CRO market."

The Indian CRO market is also drive by a large, easy-to-access, treatment-naive population; a high degree of available cost arbitrage of up to 30%-50% over U.S.; and an improved regulatory environment. The market growth is further bolstered by the Drug Controller General of India’s (DCGI) efforts to create a favorable environment for clinical trials. The improved regulatory environment possessing stringent enforcement laws will also bring more credibility to trials in India.

However, increasing competition, quality concerns and lack of quality infrastructure in smaller tier II sites are some factors that impede the growth rate of the CRO market.
"Reliability and consumer confidence in Indian clinical trials data is lacking, greatly impacting the CRO market," elaborated the analyst. "This is the result of a number of small-scale CROs having compromised on the standard of their studies in their bid to compete."

As more established CROs continue to grow, with reliable data and well-established clientele, the impact of this restraint is expected to diminish. The market will also be supported by India's attractiveness as a small base with low costs, high-standard practices, and growing interest from multinationals to include the country as a preferred clinical trials site for their studies.

"Developing a single-window clearance for clinical trials as well as clear guidelines on the types of international/global trials that can be performed on the Indian population will shore up CRO market growth," noted the analyst. "Indian CROs should focus on developing a steep learning curve by collaborating with selected international CROs and merge their talents."

Overall, market participants need to balance regulatory issues, breadth of services and data quality with cost competitiveness, a bigger footprint and innovation to grow their market share, according to the analyst.

Edible Vaccines - A novel approach towards immunization

Future prospects of edible vaccines.

Although still at an early stage of development, the experimental know-how and results strongly suggest that plant derived edible vaccines are likely to become a reality in the next few years. Future research will demonstrate if these vaccines meet the standards of quality (purity, potency, safety and efficacy) defined for vaccines by the WHO.

In future, a great ability for the immunization throughout the glob with the use of edible vaccine can be possible with its economic production will lower down the cost of immunization, separation and purification is easy and pathogenic contamination can be avoided therefore safe, no constricted criteria for its stoarge so can be stored near the site of use, aseptic condition dose not require for oral immunization as it is given through oral route.

GM-plant (Genetically modified plants) may be grown in field and clinical trials are required to define the risk/benefit ration of the GM-plant before registration is granted.  In most countries, plants engineered to produce vaccines fall under the very restrictive rules set up to control GM-crop plants. The present concern, especially in Europe, over the use of biotechnology for the genetic improvement of crop plants also negatively affects the acceptance of GM-plants for medicinal use. 

As a consequence, while the demonstration that plant-derived vaccines are effective on populations at risk is expected to arrive within 1-2 years, a further quarantine of 2-3 years will be required in order to fulfill requirements for registration and marketing. It is hoped that simpler rules will be set up for GM-plants producing vaccines and that they are seen as clearly and legally distinct from GM-plants grown for nutrition purposes.

COINS COLLECTION - INDIA

As we celebrate the 66th year of independence, we'd like to share some interesting facts about India

Interesting Facts about India

• India never invaded any country in her last 100000 years of history.
•  When many cultures were only nomadic forest dwellers over 5000 years ago, Indians established Harappan culture in Sindhu Valley (Indus Valley Civilization)
• Chess was invented in India.
• Algebra, Trigonometry and Calculus are studies, which originated in India.
• The 'Place Value System' and the 'Decimal System' were developed in India in 100 B.C.
• India is the largest democracy in the world, the 7th largest Country in the world, and one of the most ancient civilizations.
• The game of Snakes & Ladders was created by the 13th century poet saint Gyandev. It was originally called 'Mokshapat'. The ladders in the game represented virtues and the snakes indicated vices. The game was played with cowrie shells and dices. In time, the game underwent several modifications, but its meaning remained the same, i.e. good deeds take people to heaven and evil to a cycle of re-births.
• India has the largest number of Post Offices in the world.
• The largest employer in India is the Indian Railways, employing over a million people.
• The world's first university was established in Takshila in 700 BC. More than 10,500 students from all over the world studied more than 60 subjects. The University of Nalanda built in the 4th century was one of the greatest achievements of ancient India in the field of education.
• Ayurveda is the earliest school of medicine known to mankind. The Father of Medicine, Charaka, consolidated Ayurveda 2500 years ago.
• India was one of the richest countries till the time of British rule in the early 17th Century. Christopher Columbus, attracted by India's wealth, had come looking for a sea route to India when he discovered America by mistake.
• The Art of Navigation & Navigating was born in the river Sindh over 6000 years ago. The very word Navigation is derived from the Sanskrit word 'NAVGATIH'. The word navy is also derived from the Sanskrit word 'Nou'.
• Bhaskaracharya rightly calculated the time taken by the earth to orbit the Sun hundreds of years before the astronomer Smart. According to his calculation, the time taken by the Earth to orbit the Sun was 365.258756484 days.
• The value of "pi" was first calculated by the Indian Mathematician Budhayana, and he explained the concept of what is known as the Pythagorean Theorem. He discovered this in the 6th century, long before the European mathematicians.
• Algebra, Trigonometry and Calculus also originated in India.Quadratic Equations were used by Sridharacharya in the 11th century. The largest numbers the Greeks and the Romans used were 106 whereas Hindus used numbers as big as 10*53 (i.e. 10 to the power of 53) with specific names as early as 5000 B.C.during the Vedic period.Even today, the largest used number is Terra: 10*12(10 to the power of 12).
• Sushruta is regarded as the Father of Surgery. Over2600 years ago Sushrata & his team conducted complicated surgeries like cataract, artificial limbs, cesareans, fractures, urinary stones, plastic surgery and brain surgeries.
• India exports software to 90 countries.
• Martial Arts were first created in India, and later spread to Asia by Buddhist missionaries.
• Yoga has its origins in India and has existed for over 5,000 years.

BE PROUD TO BE AN INDIAN. जय हिंद

ACRI has consistently achieved 100% placement. ACRI appreciates the collective hard work of placement, academic and marketing team. Keep up the good work.