Overview of This Study:

This study involved the extensive use of both primary and secondary sources. The research process involved the study of various factors affecting the industry to identify the segmentation types, industry trends, key players, competitive landscape, fundamental market dynamics, and key player strategies.

Market Size Estimation Methodology:

A detailed market estimation approach was followed to estimate and validate the size of the global clinical trial management system market and other dependent submarkets.

# The key players in the global clinical trial management system market were identified through secondary research, and their global market shares were determined through primary and secondary research.

# The research methodology includes the study of the annual and quarterly financial reports of the top market players as well as interviews with industry experts for key insights on the global clinical trial management system market.

# All percentage shares, splits, and breakdowns were determined by using secondary sources and verified through primary sources.

# All the possible parameters that affect the market segments covered in this research study have been accounted for, viewed in extensive detail, verified through primary research, and analyzed to get the final quantitative and qualitative data.

The above-mentioned data was consolidated and added with detailed inputs and analysis from MarketsandMarkets and presented in this report.

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Data Triangulation:

After deriving the overall clinical trial management system market value data from the market size estimation process, the total market value data was split into several segments and subsegments. To complete the overall market engineering process and arrive at the exact statistics for all the segments, data triangulation and market breakdown procedures were employed wherever applicable. The data was triangulated by studying various qualitative and quantitative variables as well as by analyzing regional trends for both the demand- and supply-side macroindicators.

Projected Surge in Revenue Generation:

The clinical trial management system market is projected to reach USD 1,590 million by 2025, at a CAGR of 14.7 % during the forecast period. The growth of the CTMS market is driven by increasing number of clinical trials, and government support for research trials. However, budget constraints and limited knowledge about advanced CTMS solutions restrain the market growth.

Restraint: Budget Constraints

Small and mid-sized customer facilities often face financial constraints for clinical trials due to limited private funding, rigorous regulatory mandates, and financial outlook. This also includes ineffective site selection, poor study design & trial execution, safety issues, and dropouts due to practical or financial issues. Furthermore, the time and capital required to complete a trial increase at each phase.

The total cost of a Phase III failure includes the cost of all previous phases, plus the time that could have been used to trial a different drug. Each failed trial contributes to the rising costs of biopharma R&D. Although R&D spending in the life science industry is rising, start-ups and SMEs still face budget constraints, which affect their decision to purchase CTMS solutions. Due to uncertainties in product approvals, undue delays in product approvals, and long gestation periods, private investors usually prefer established firms to invest in rather than start-ups and SMEs.

Opportunity: Investment in effective digital infrastructure and agility in technological adoption

The need to comply with stringent regulations has been crucial to expediting the adoption of new technology in research. Although the supply of technology has been increasing and the regulation of innovative methods is easing, pharmaceutical companies have been slow to use emerging technologies due to the uncertainty prevailing around this space and a highly fragmented supply market.

Lately, pharma companies have increased expenditure on AI and big data analytics, given their transformative supremacy over the R&D process and cost savings. Fear of rivalry in the market and the need for business transformation and agility are key forces driving huge investments in R&D technologies. Hence, pharma companies must recognize outward innovation through supplier benchmarking in each of these categories and be involved in early engagement through co-development to stay competitive.

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COVID-19 Impact on the global Clinical Trial Management Market

Due to the COVID-19 outbreak, medical practices across all specialties and practices are under immense pressure; providers worldwide have been overwhelmed by the large and increasing number of patients. The emergence of this pandemic has posed severe financial constraints on pharma-biopharma companies in several countries. In this regard, CTMS has proven to be very helpful, as it allows industrial & academic researchers to monitor patients using digitally connected platforms while helping to organize & evaluate the clinical data for regulatory submissions.

The COVID-19 pandemic has also increased the need for social distancing among physicians and patients, which has driven the demand for remote patient monitoring and digital solutions for clinical research data gathering and analysis. Various players in this market have introduced COVID-19-associated features into their existing EHRs, which are being made available to users free of cost.

Recent Developments:

# In June 2019, Parexel International Corporation (US) launched an enhanced integrated outsourcing delivery model for functional service provider (FSP) services at the DIA 2019 Global Annual Meeting in San Diego, US.

# In May 2019, Bio-optronics (US) launched three products to the CCTrialSuite basket application—CCeSource, CCeReg & CCeConsent.

# In June 2018, Bioclinica (US) launched eClinical Solution namely the SMART Technology Suite.

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