Clinical Trials Software Market, 2022-2035: Distribution by Type of Deployment (on-cloud, on-premises), Type of Delivery (web-based, remote monitoring), Features of software (EDC, eCOA/ePRO, eConsent) and Geographical Regions (North America, Europe and As

Clinical Trials Software Market, 2022-2035: Distribution by Type of Deployment (on-cloud, on-premises), Type of Delivery (web-based, remote monitoring), Features of software (EDC, eCOA/ePRO, eConsent) and Geographical Regions (North America, Europe and Asia-Pacific)

1. It is a well-known fact that clinical trials form an integral part of the overall drug development process, enabling innovators to assess safety and efficacy of their drug candidates / devices. These studies account for around 50% of the total time and capital invested in the development process. However, the conduct of trials is often fraught with several challenges, including scientific and operational complexity, concerns associated with recruitment and retention of suitable patients, issues related to data handling and increasingly stringent regulatory guidelines. In fact, the failure of a clinical trial can impose an enormous financial burden on sponsors, estimated to be in the range of USD 800 million (in case of therapies with limited applications) to USD 1.4 billion (for a drug that is anticipated to be a blockbuster). Further, during the COVID-19 pandemic, the conduct of clinical trials has become increasingly difficult. In order to address these challenges, players engaged in the pharmaceutical industry have leveraged novel and advanced digital health technologies, such as mobile devices, advanced applications, remote monitoring devices, telemedicine, and online social interaction platforms for virtual conduct of clinical trials. Various clinical trials software, including EDC, eCOA/ePRO, and eConsent integrated clinical study automation software, are also being recruited to collect data at each stage of the trial, improve trial participant recruitment and retention, provide eConsent, measure real-time clinical outcomes, and track adverse events in real-time.

Virtual clinical trials software solutions have the potential to induce substantial digital changes in clinical research methodology, resulting in a more patient-centric, cost-effective and easy to manage approach. They enable the participants to participate from the comfort of their own homes rather than traveling to a study location, which enhance participant engagement and retention. At present, several companies are engaged in the development of clinical trials software, which allow drug developers to enhance the quality of their clinical products and reduce the time to get a product to market. The market has witnessed substantial partnership activity over the last few years. The activity in this segment has also attracted the attention of both private and public sector investors / investment funds, which have extended financial support to the initiatives of capable developer companies. Driven by the substantial progress in this domain, encouraging virtual clinical trial results, and ongoing technological advancement, the clinical trials software market is anticipated to grow at a commendable pace in the mid to long term.

1.1. SCOPE OF THE REPORT
The Clinical Trials Software Market, 2022-2035: Distribution by Type of Deployment (on-cloud, on-premises), Type of Delivery (web-based, remote monitoring), Features of software (EDC, eCOA/ePRO, eConsent) and Geographical Regions (North America, Europe and Asia-Pacific) report features an extensive study of the current market landscape and future opportunity for the players involved in the development of clinical trials software. The study presents an in-depth analysis, highlighting the capabilities of various stakeholders engaged in this domain, across different geographies. Amongst other elements, the report includes:

An overview of clinical trials software market, featuring a detailed market landscape analysis based on several relevant parameters, such as type of deployment (on-cloud, on-premises), type of delivery (web-based, remote monitoring), type of end-user (pharmaceuticals, biotechnology, CROs), features of software (EDC, eCOA/ePRO, eConsent), trial design (decentralized, site-based, hybrid, randomized, case control, cohort), type of technology (IVRS, IWRS). It also provides insights on developer landscape along with the analysis based on year of establishment, company size, location of headquarters.

An insightful competitiveness analysis of clinical trials software developers, taking into consideration the supplier strength (based on expertise of the manufacturer), product portfolio strength and service applicability.

An analysis of the partnerships that have been inked by various stakeholders engaged in the development of clinical trials software, during the period 2016-2021, covering service agreements, research agreements, licensing agreements, product development, product integration, product utilization and other types of partnership deals.

An analysis of the mergers and acquisitions of various stakeholders engaged in the development of clinical trials software, during the period 2016-2021.

An analysis of the investments made at various stages of development of clinical trials software companies engaged in this field, covering instances of seed funding, venture capital funding, debt financing, grant and other equity.

Tabulated profiles of the key players providing clinical trials software. Each profile includes an overview of the company, product portfolio, recent developments, and an informed future outlook.

One of the key objectives of the report was to estimate the future growth potential of clinical trials software market, over the coming decade. We have provided informed estimates on the financial evolution of the market for the period 2021-2035. For this purpose, we have segmented the future opportunity across the following market segments: type of deployment (on-cloud, on-premises), type of delivery (web-based, remote monitoring), key players and geographical regions (North America, Europe and Asia-Pacific). In order to account for uncertainties and to add robustness to our model, we have provided three market forecast scenarios, portraying the conservative, base and optimistic tracks of the anticipated industry’s growth.

1.2. KEY QUESTIONS ANSWERED
Who are the leading players engaged in the development of clinical trials software solutions?
Which region(s) will occupy the maximum market share in clinical trials software domain?
Who are the key venture capitalists / strategic investors funding the clinical trials software development initiatives?
Which partnership models are commonly adopted by stakeholders engaged in the development of clinical trials software solutions?
Which factors are likely to influence the evolution of this market?
How is the current and future market opportunity likely to be distributed across key market segments?

1.3. RESEARCH METHODOLOGY
The data presented in this report has been gathered via secondary and primary research. For all our projects, we conduct interviews with experts in the area (academia, industry and other associations) to solicit their opinions on emerging trends in the market. This information is primarily useful for us to draw out our own opinion on how the market will evolve across different regions and technology segments. Wherever possible, the available data has been validated from multiple sources of information.

The secondary sources of information include:
Annual reports
Investor presentations
SEC filings
Industry databases
News releases from company websites
Government policy documents
Industry analysts’ views

While the focus has been on forecasting the market till 2035, the report also provides our independent views on various non-commercial trends emerging in this industry. This opinion is solely based on our knowledge, research and understanding of the relevant market trends gathered from various secondary and primary sources of information.

1.4. CHAPTER OUTLINES
Chapter 2 is an executive summary of the key insights captured in our research. It offers a high-level view on the current state of the clinical trials software market and its likely evolution in the short to-mid to long term

Chapter 3 highlights the existing constraints in clinical research and patient recruitment and retention-related challenges. It provides an overview of the virtual clinical trials and various clinical trials software. In addition, it discusses various opportunities and challenges associated with virtual clinical trials management and the future perspectives.

Chapter 4 presents a detailed assessment of the current market landscape of clinical trials software along with information on type of deployment (on-cloud, on-premises), type of delivery (web-based, remote monitoring) and end-users (pharmaceuticals, CROs, biotechnology), trial design (decentralized, site-based, hybrid, randomized, case control, cohort), and type of technology (IVRS, IWRS). In addition, it provides an overview of the clinical trials software developer landscape, highlighting the players that are active in this domain. It includes information on their year of establishment, company size (in terms of number of employees) and location of their respective headquarters. Further, we have presented a logo landscape, highlighting the distribution of the developers based on company size and location of headquarters.

Chapter 5 includes profiles of the key players engaged in the development of clinical trials software (shortlisted based on company size). Each profile features a brief overview of the company, details on product portfolio, recent developments, and an informed future outlook.

Chapter 6 is an insightful three-dimensional bubble chart representation, highlighting the competitive analysis of clinical trials software developers, taking into consideration the supplier strength (based on the expertise of the manufacturer), product portfolio strength, and service applicability.

Chapter 7 features a detailed analysis of the partnerships and collaborations that have been inked in this domain since 2016, covering product development agreements, research and development agreements, licensing agreements, clinical trial agreements, licensing and manufacturing agreements, product development and commercialization manufacturing agreements, joint venture, acquisition and other relevant types of deals

Chapter 8 features a detailed analysis of the mergers and acquisitions that have been inked in this domain since 2016, covering mergers and acquisitions.

Chapter 9 provides an analysis of the key investments made since 2016 at various stages of development of companies engaged in this domain, based on the year of investment, number of funding instances, amount invested and type of funding, highlighting most active players (in terms of number of funding instances and amount raised) and most active investors (in terms of number of funding instances).

Chapter 10 features an elaborate discussion on the future market potential of clinical trials software. The chapter provides insights on the likely distribution of the current and forecasted opportunity across type of deployment, type of delivery, key players and geographical regions (North America, Europe and Asia-Pacific).

Chapter 11 is a summary of the overall report, wherein we have mentioned all the key facts and figures described in the previous chapters.

Chapter 12 is an appendix that contains tabulated data and numbers for all the figures provided in the report.

Chapter 13 is an appendix, which provides a list of companies and organizations mentioned in the report.

LIST OF COMPANIES AND ORGANIZATIONS

The following companies and organizations have been mentioned in the report:
1. ClinOne
2. Clinical Ink
3. DatStat (Acquired by SCI Solutions)
4. Advarra
5. Castor
6. Kayentis
7. Interlace Health
8. Crucial Data Solutions (CDS)
9. Cloudbyz
10. Datacubed Health
11. TransCelerate Biopharma
12. 5thPort
13. Datatrak
14. THREAD
15. Dacima
16. IBM
17. REDcap Cloud
18. Axiom
19. Evado
20. DSG
21. AssistRx
22. Jeeva Informatics
23. eClinicalHealth
24. ObvioHealth
25. StudyKIK (Acquired by Syneos Health)
26. Clinion
27. TrialStat
28. Acceliant
29. DFnet
30. DM 365
31. Clindox
32. OnlineCRF
33. SMART-TRIAL
34. MEDNET
35. Octalsoft
36. Clinevo
37. Ennov
38. XClinical
39. RodanoTech
40. ITClinical
41. CROS NT
42. IDDI
43. CRScube
44. IVR Clinical Concepts
45. Prelude Dynamics
46. Clinical Biometrics Solutions
47. Medidata
48. Signant Health
49. Medrio
50. Medable
51. DrugDev (Acquired by IQVIA)
52. McDougall Scientific
53. Anju Software
54. ECLIPSE
55. IQVIA
56. Calyx
57. Oracle Cloud Infrastructure
58. CLINDEX FORTRESS MEDICAL SYSTEMS
59. ClinCapture
60. Climedo Health
61. OpenClinica
62. Science 37
63. VirTrial (Acquired by Signant Health)
64. Curavit
65. BSI
66. Realtime
67. Veeva Systems
68. encapsia
69. ArisGlobal
70. Quanticate
71. Arithmos
72. Healthentia
73. Clario (Bioclinica and ERT)
74. Xolomon

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