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The process of collection, documentation, and data storage, which are critical for clinical trials or procedures and to biotechnology companies and pharmaceutical manufacturers is termed as Clinical Data Management (CDM). Clinical data management tool is employed in clinical research for managing the data of a clinical trial. Data management is a process of collection, integration, and management of subject data in compliance with regulatory standards. Clinical data management is a fundamental phase in clinical research leading to the generation of high-quality, reliable, and statistically comprehensive data to reduce time duration from drug development to marketing. The clinical data is captured in a paper or electronic data capture format. Pharma companies, contract research organizations, and IT companies are involved in CDM activities. Data is collected from multiple sources and stored in a patient-centric fashion in a data repository commonly known as clinical data repository.

The major goal of CDM is to assure that the data support deductions drawn from the research to protect public health and trust in marketed therapeutics. Outsourcing of clinical data management to IT service providers is done by the organizations to focus on core competencies of clinical research and pharmaceuticals, reduction in operational expenditure, and investment in research and development activities.

Rising number of clinical trials drives the clinical data management market

Advantages of web-based data collection tools such as reduced time and ease in data entry, low cost, flexibility in format, and the ability to capture additional response-set information drive the clinical data management market. Additionally, high levels of productivity and efficiency offered by clinical data management are expected to redefine the traditional data management process by the companies thereby augmenting the clinical data management market growth. Also, increase in research and development expenditure of clinical research and life science industries coupled with increasing number of clinical trials is a factor contributing to the growth of clinical data management market.

Focus on high-quality clinical data by Oracle Clinical segment fuels the market growth

The global clinical data management market is segmented on the basis of tools, service, delivery mode, end-use industry, and geography.

On the basis of tools, the global clinical data management market is segmented into:

  • Oracle Clinical
  • Clintrial
  • Macro
  • Rave
  • eClinical Suite

On the basis of services, the global clinical data management market is segmented into:

  • Case Report Form (CRF) Designing
  • Data Entry and Validation
  • Discrepancy Management
  • Medical Coding
  • Others

On the basis of delivery mode, the global clinical data management market is segmented into:

  • Licensed Enterprise
  • Web–based
  • Cloud-based

On the basis of end-use industry, the global clinical data management market is segmented into:

  • Biotechnology
  • Pharmaceutical
  • Clinical Research Organizations
  • Medical Devices

North America is expected to dominate the market due to rise in demand for patient data standardization

Regional segmentation of clinical data management market by Coherent Market Insights comprises North America, Europe, Asia Pacific, Latin America, Middle East, and Africa. According to the National Institutes of Health estimates in 2015, around 89,528 clinical trials were conducted in the U.S., which, in turn, raised the demand for storing comprehensive statistical patient data in. Moreover, the growth of North America market is driven by increasing need for data standardization and rising investments by biotechnology and pharmaceutical companies in research and development. The surging growth in Asia Pacific is attributed to a number of factors including rise in outsourcing of clinical trials, availability of diverse patient population, and less regulatory guidelines by the government.

Key players operating the clinical data management market include OmniComm Systems, Oracle Corporation, BioClinicia, ERT, PHT Corporation, MedNet Solutions Inc., PAREXEL International Corporation, eClinical Solutions Inc., Datatrak International Inc., and Medidata Solutions, Inc.


Research Methodology

Coherent Market Insights followsa comprehensive research methodology focused on providing the most precise market analysis. The company leverages a data triangulation model which helps company to gauge the market dynamics and provide accurate estimates. Key components of the research methodologies followed for all our market reports include:

  • Primary Research (Trade Surveys and Experts Interviews)
  • Desk Research
  • Proprietor Data Analytics Model

In addition to this, Coherent Market Insights has access to a wide range of the regional and global reputed paid data bases, which helps the company to figure out the regional and global market trends and dynamics. The company analyses the industry from the 360 Degree Perspective i.e. from the Supply Side and Demand Side which enables us to provide granular details of the entire ecosystem for each study. Finally, a Top-Down approach and Bottom-Up approach is followed to arrive at ultimate research findings.

Data Triangulation Methodology | Coherent Market Insights

Coherent Market Insights desk research is based on a principle set of research techniques:

  • National level desk research: It Includes research analysis of regional players, regional regulatory bodies, regional trade associations, and regional organization.
  • Multinational level desk research: The research team keeps a track of multinational players, global regulatory bodies, global trade associations, and global organization.

Coherent Market Insights has a large amount of in-house repository of industry database. This is leveraged as a burner for initiating a new research study. Key secondary sources include:

  • Governmental bodies, National and international social welfare institutions, and organizations creating economic policies among others.
  • Trade association, National and international media and trade press.
  • Company Annual reports, SEC filings, Corporate Presentations, press release, news, and specification sheet of manufacturers, system integrators, brick and mortar - distributors and retailers, and third party online commerce players.
  • Scientific journals, and other technical magazines and whitepapers.

Market Analysis | Coherent Market Insights

Preliminary Data Mining

The raw data is obtained through the secondary findings, in house repositories, and trade surveys. It is then filtered to ensure that the relevant information including industry dynamics, trends, and outlook is retained for further research process.

Data Standardization

Holistic approach is used to ensure that the granular and uncommon parameters are taken into consideration to ensure accurate results. The information from the paid databases are further combined to the raw data in order to standardize it.

Coherent Statistical model

We arrive at our final research findings through simulation models. Coherent Data Analytics Model is a statistical tool that helps company to forecast market estimates. Few of the parameters considered as a part of the statistical model include:

  • Micro-economic indicators
  • Macro-economic indicators
  • Environmental indicators
  • Socio-political indicators
  • Technology indicators

Data Processing

Once the findings are derived from the statistical model, large volume of data is process to confirm accurate research results. Data analytics and processing tools are adopted to process large chunk of collected informative data. In case, a client customizes the study during the process, the research finding till then are benchmarked, and the process for new research requirement is initiated again.

Data Validation

This is the most crucial stage of the research process. Primary Interviews are conducted to validate the data and analysis. This helps in achieving the following purposes:

  • It provides first-hand information on the market dynamics, outlook, and growth parameters.
  • Industry experts validates the estimates which helps the company to cement the on-going research study.
  • Primary research includes online surveys, face-to face interviews, and telephonic interviews.

The primary research is conducted with the ecosystem players including, but not limited to:

  • Raw Material Suppliers
  • Manufacturers
  • System Integrators
  • Distributors
  • End-users

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