Vaccines – Tracking Multiple Doses

Challenge

Vaccine dosing studies usually require information to be entered with high accuracy in a short amount of time. Blood draws often occur every 10 to 15 minutes during an initial time period and then hourly or every several hours for a second time period. When collecting information on paper for several cases at the same time, this can become challenging since the data requires the phlebotomist’s signature, and the date and time the information was recorded. Additional observations, such as the case’s physical reactions (injection site reactions, mood, level of energy or lethargy, etc.) are often required in addition to lab data.  Depending on study objectives, the extent of data collection can vary and collecting large amounts of data in a short time on paper can be stressful and prone to errors. Further, when labs results are returned and analyzed, the results must be integrated with existing patient data. Each data entry process on paper introduces the change for human entry errors. The challenge was to develop an electronic system that would streamline the data collection process, reduce errors, and stress.

Proposal

Prelude Dynamics proposed the study use VISION™, an electronic data collection system, to allow researchers to capture information in real-time, follow the natural work flow of the study process, and ease data collection. The proposed system would automatically integrate lab results into patient files, compare them to established lab normals and flag outliers, and allow the researcher to determine if the flagged outliers were clinically significant.

Background

Vaccine trials usually consist of understanding real-time antibody development occurring post-introduction of the vaccine. Generally, different dose amounts are compared to determine the optimal dose to produce an effective vaccine. This requires the researcher to collect multiple blood samples after initial dosing. The intervals of the blood collection are typically every 10 to 15 minutes for an initial time period and then hourly or every several hours for secondary time period.

During each blood collection event, additional data on various physical responses to the vaccine is also collected (blood pressure, heart rate, etc.). Depending on the method of vaccine administration, other observations are recorded, such as injection site redness, heat, and pain if administered via injection, or coughing rate and breaths per minute if administered via breathing. These observations demand close attention from the researcher and increase the stress level the researcher experiences during data collection.

Historically, vaccine studies are costly because the researchers-to-subjects ratio of at each data collection event is low to allow enough time to collect the data. Development of an electronic data capture system that streamlines the process can increase the accuracy of data collection, and allow for more subjects to undergo the vaccine therapy simultaneously, ultimately lowering costs, decreasing data collection time, and reducing time to market.

Solution

Prelude Dynamics proposed to utilize VISION™ to develop an electronic data system for vaccine trials that:

  • Includes an integrated time management system that prompts the researcher to administer the doses or collect specific data within designated timeframes.
  • Expedites data entry of dosing or blood draw by collecting researcher information, data and time stamp for each data collection event with one button click.
  • Standardizes data collection by allowing researchers to select designated options rather than writing out observations.
  • Allows researchers to augment the clickable answers with additional details when pertinent.
  • Alerts researchers immediately of missing required data to ensure the data is collected prior to the data collection event.
  • Integrates lab analysis into patient files, including notifying researchers of the receipt of lab results and flagging outlying results based on designated lab normal values.
  • Allows monitors and sponsors to view data collection in real-time even when they are located remotely so that if data needs to be queried, it can occur quickly.
  • Allows sponsors and researchers to examine demographic results of the data collected to date to allow mid-study monitoring.

VISION™ contains administrative panels that allow the sponsor to determine the frequency of vaccine dosing and challenge dosing and blood draws. Acceptable timeframe deviation ranges can be entered into this panel. When site personnel or researchers initiate the time clock for the case by clicking the “now” time button, VISION™ automatically starts the countdown to the next event and displays any data that must be collected in the interim. When the “now” button is clicked, the user’s ID, date, and time stamp are recorded in the system, eliminating time to write the dame and time, reducing future data entry costs, and increasing the accuracy of data collection. Once the researcher clicks “save,” the data entered is hidden. When it is time for the next event (blood draw, dosing, etc.), the system alerts the researcher on the screen and displays the data to be collected for that event. Because VISION™ is an online data collection system, field researchers are able to access the study and enter data on any mobile device.

These features allow for dosing and blood draws to occur for multiple cases in a tiered fashion, which maximizes the researchers’ time without compromising data integrity. When multiple cases are being entered simultaneously, switching between patients can be done either through the list page or by entering the case ID and hitting the search button. The system is constantly communicating with the researcher what needs to occur next and what data needs to be collected.

The additional data to be collected between doses or draws is standardized in order to allow entry through selection from a drop down menu of choices, radio buttons or checkboxes. When additional information needs to be added, comments or notes can be added directly to the pertinent field. Additionally, if needed, free text fields can be provided for entry of comments or in response to certain questions. Edit checks that fire when the form is saved alert the researcher to missing or out-of-range information. VISION™ collects a full audit trail of all data recorded in the system, and each data point is stamped with who entered the data when (date/time).

While lab analyses do take time, VISION™ allows the labs to enter data directly into the system, and the researcher receives an email notification of the lab data arrival. The lab results are automatically compared with the designated lab normal ranges and out-of-range data is flagged to allow the researcher to determine if it is clinically significant.

Remotely located sponsors or other researchers can access data in real-time, which allows queries to appear in the system at the site during data collection. Site or field personnel respond within the system to the queries, and can collect additional data immediately.

For vaccines using injections as the administration route, digital photos can be captured and uploaded into the system. An additional module allows measurements to be collected.

VISION™ also contains pre-existing summaries which assist in monitoring the data collected at the patient level, at each site or for the study as a whole. Using VISION™’s search and filter capacity allows these summaries to display data for only cases fitting the search criteria. Additionally, designated users can create ad-hoc reports to monitor additional criteria and answer important research questions. The data within the system is available for export 24/7/365 with the appropriate user permission. Export features the ability to export in multiple formats, including SAS-ready format.

Results & Benefits

During the initial testing of the system, researchers collected data both on paper as well as within VISION™. Within minutes, it was obvious that the VISION™ solution was far superior, reduced time and data entry errors, and was well liked by the researchers. In fact, the users were so impressed with VISION™ that they called upper level management to come observe the difference at the last minute. Upper management was also very impressed at the capacity of VISION™ to streamline the process, and agreed there were cost savings and efficiency benefits to their studies.

Real-time data is entered into VISION™ and has eliminated the need for paper CRF collection. Researchers spend less time entering data and the data entered is standardized as they select from designated options. In cases where text entry fields are available, as items are entered, they become available for future selection in a drop down menu adding real-time standardization to data entry.

Additionally, data is accessible in real time for review, analysis, export, or additional data entry. Users have access to all digital photographs, and labs are compared to designated lab normals and outliers flagged for analysis. Users report the streamlining of the process has helped reduce errors and improved efficiency.

They are currently working on standardizing additional data collection forms so that they can be used as templates for future studies further standardizing their studies. Meanwhile, Prelude is working on developing a way to provide them with the ability to pick the forms they want to use from their existing library of forms via an administrative panel so they can design future studies faster and at a lower cost. Additionally, within each form, they will have the ability to select what modules of information they desire to use on the form for that particular study.

About Prelude Dynamics & VISION™

Prelude Dynamics is a global provider of customized web-based software systems for data collection, analysis and management of clinical trials, studies and registries. We streamline eClinical operations through our unique and innovative VISION™ software system, which allows us to rapidly configure data collection solutions for pharmaceutical, CRO, medical device, animal health, and university organizations.

Capturing Subject Scales

Challenge

Collecting data entered on a Visual Analog Scale (VAS) using paper is always subject to data measurement and entry errors. The challenge was to replicate the paper process electronically in order to eliminate post-data collection measurement and data entry errors. This would eliminate the need for multiple measures and duplicate data entry reducing errors and cost. This was especially important for this study as each data collection period consisted of 26 VAS and was repeated 5 times per subject throughout the study.

Adding to the challenge’s complexity was the necessary capability of the VAS line to be standardized to exactly 10 millimeters or expanded to fit across the screen of the data entry device. This complexity required logistics development to standardize the analysis and/or data capture of the information when different line sizes are used by different individuals and devices. In this case, the data collection location required the use of mobile device to collect the data. Further, if a subject received a certain combination of subscale scores during the pre-screening or follow up visits, the researcher was to receive an alert that the subject needed to be withdrawn from the study.

And finally, the Sponsor required the ability to monitor progress mid-study, including a table of results and a graph across time on a per-subject basis, as well as aggregated across sites.

Proposal

Prelude Dynamics proposed to use VISION™, an electronic data collection system, to accurately capture real-time study data and allow study participants to respond to questions using a VAS on a mobile device.

An administrative panel was proposed so that site-based researchers could provide access to appropriate set of scales.  The scales designation would be set up such that the VAS scale could be fixed or varied, depending on the researcher’s preferences or the visual ability of the study participant.

The proposal included tables and graphs designed to aggregate the data for mid-study review, including on a per-subject basis or across sites or study visits. Users could further refine mid-study reviews by selecting between complete scales or a single subscale. Utilizing VISION™’s standard features available to all clients, the Sponsor could customize ad-hoc reports as well as search/filter the data to be analyzed in the tables, graphs and ad-hoc reports.

Background

Using paper-based VAS creates a cumbersome post-data collection process because the responses have to be accurately measured and recorded. This generally requires a minimum two measurements, the comparison between them to ensure they fall within an acceptable error range, and the collection of an additional measure when they do not. Each measurement is an opportunity for error, and the process is time-consuming and costly. Nevertheless, VAS scales are popular because they provide an accurate scale and allow more variability to be measured between subject results. Instead of being confined to 10 data points, a maximum generally used in Likert scales, VAS allows for 100 data points to be measured when the standard 10 cm line is used and measures are taken every millimeter. Likert scales are also limited by the bias introduced through the labeling of each choice. VAS provides a greater degree of accuracy and are known to better detect clinically significant changes.

Solution

A solution to the issue is to allow subjects to enter information on an electronic VAS directly onto a mobile device using VISION™, an electronic data capture system. Prelude provided the researchers with an administrative panel where they could enter basic subject information, assign a temporary password, and activate each survey. The researchers then instructed the subjects on how to change their password and use the system. As subjects entered the data directly on the mobile device, it became available for review on the administrative panel as well as for analysis via summaries (tables and graphs) and for use in ad-hoc reports.

VISION™’s standard summaries, which assist in monitoring the data being collected on a per-subject, per-site or whole-study basis, were customized so that researchers could view tables and graphs across time on a per-subject basis, or a scale or subscale basis. Using VISION™’s search and filter capacity allows these summaries to display data of only the cases fitting the search criteria. Additionally, certain users have permissions to create and export ad-hoc reports, which can be used to monitor additional criteria or to answer research questions. The data within the system is available for export 24/7/365, including the ability to export in multiple formats (e.g., SAS-ready format).

Results & Benefits

As subjects select a data point on the VAS, real-time data is entered into VISION™. This eliminates the need for post-data collection measurement and data entry, reduces the opportunity for errors, and lowers cost to measure and duplicate data entry. VISION™ also prevents a subject from changing an entered answer, which ensures they answer in real-time and are not able to enter the information retrospectively or prospectively. Results are automatically calculated for the subscales. If a subject’s scores fall outside of the required threshold, site personnel receive immediate feedback that the subject does not qualify for the study.

Another VISION™ advanced feature is the Randomization module. When a subject is removed from the study, VISION™’s Randomization module works behind the scenes to reassign the removed subject’s treatment code to a new subject. This ensures that sufficient cases were assigned for each treatment group to maintain the study’s viability. All collected data is accessible in real time for query, review, analysis and export.

About Prelude Dynamics & VISION™

Prelude Dynamics is a global provider of customized web-based software systems for data collection, analysis and management of clinical trials, studies and registries. We streamline eClinical operations through our unique and innovative VISION™ software system, which allows us to rapidly configure data collection solutions for pharmaceutical, CRO, medical device, animal health, and university organizations.

Randomization

Challenge

Ensuring that patients are appropriately randomized to the correct treatment group is a critical factor for all clinical studies. Additionally, it is imperative that designated study personnel are masked to the assigned treatment group unless there is a medical necessity to disclose. Ideally, at the end of the study, there is a proportional number of cases in each treatment group as planned in the study design.

However, a variety of issues can occur that compromise the desired treatment group mix.  For example, a case might be accidentally given the wrong treatment or a case that was randomized might be terminated early from the study. In some cases, in order to enroll enough patients, there is a need to allow certain sites to add additional patients. When a randomization table is used, even though there might be a few additional randomization lines available, more often than not, it is necessary to generate additional randomized treatment groups to support the site case enrollment expansion.

Furthermore, when either electronic or paper-based randomization tables are used, study personnel designated to be masked may accidentally become unblended due to simple human error, such as the randomization table mistakenly being left out on a table.

Additionally, sometimes the randomization strategy needs to be applied across the whole study rather than just at the site level. A study-wide randomization makes it more difficult for site-based personnel to try to pre-empt what treatment group the case might be assigned to and to start to notice trends that might allow them to start guessing what treatment each case is receiving. This is important as it is a natural behavior to try to guess and this inadvertently introduces unnecessary researcher bias.

In some cases, it may be ideal to apply multiple stratification criteria to assign cases to particular groups (for example, gender or age). When using paper-based or spreadsheet tables, adding stratification criteria is a complex proposition.

Prelude Dynamics was challenged to develop a smart electronic interface that will more easily perform randomization processes and allow for complex stratification criteria, mitigating these challenges.

Proposal

Prelude Dynamics proposed to develop an integrated dynamic randomization module to meet the challenge and to respond to given specifications for future studies. The module will allow researchers to select whether the randomization is site- or study-based, input treatment group ratios and block size, and apply multiple stratification criteria. Further, the module will reassign the treatment group for a case that does not complete the study to new enrollees, ensuring treatment group minimums and ratios are met. The module would also be automated such that randomization would only be available when inclusion/exclusion criteria have been met.

Background

The success of a clinical trial study relies on consistent randomization of patients into treatment groups and dependable masking of certain roles in order ensure biases is not introduced into the study. Generally, this means that at least one person at the site level, the treatment dispenser or coordinator, is knowledgeable about the treatment group to which each subject is assigned. Historically, this role had maintained a written table that indicated to which group the subject is assigned dependent on the enrollment order into the study.

Written randomization tables pose several challenges for the study overall. The unmasked role must ensure the randomization table is kept confidential and that information that could indicate the assigned treatment group is not accidentally verbally disclosed. Additionally, if there is inventory that needs to be kept up with, the inventory must be kept in such a manner that it does not inevitably disclose and relationship between subjects and treatment group.

When an individual is relied on to determine randomization of treatment groups, problems can occur due to human error. A subject being inadvertently given the wrong treatment is one of the biggest such problems. This would require making a decision about how to handle the next enrollee. The decision maker would have to evaluate if the next enrollee should be provided with the treatment this subject should have received, thereby skewing the order of randomization. Further, if the mistake is not discovered immediately, other subjects may have since been enrolled and the randomization ratios become harder to control and manage.

Subjects also sometimes withdraw from studies, which can cause a difference in the number of subjects per treatment group. Historically, it has been difficult or nearly impossible to guard the integrity of the study randomization and reassign the treatment group to another study. Unfortunately, subjects dropping out of the study for various reasons is a frequent and costly event.

Another problem that can be a consequence of study dropouts or inaccurate enrollment predictions is that more subjects need to be enrolled to satisfy the study design. When this occurs, there might be sites that have had more success enrolling the desired patient demographics than others, and these sites may be asked to expand the number of subjects enrolled. This presents a problem when the randomization table is exhausted, and makes it necessary for the study biostatistician to develop an appended randomization table.

Historically, it has been nearly impossible for studies to use complex stratification criteria to enroll subjects and assign treatment groups. These studies have to choose between either developing multiple randomization tables for each set of stratification criteria or simplifying the stratification criteria altogether. Additionally, if multiple randomization tables are used, the study incurs cost to train the treatment dispenser or unmasked role to use the more complicated tables. It has also historically been problematic to randomize across the study when it is conducted in different clinics.

Solution

Prelude Dynamics proposed to train users to utilize VISION™’s randomization module, which allows for dynamic randomization and was set up to handle:

  • Study-wide randomization across clinics
  • Reassignment of dropouts
  • Reassignment of accidental treatment assignment errors
  • Just-in-Time randomization
  • Dropping of treatment groups if deemed ineffective due to mid-study monitoring and statistical analysis

Results & Benefits

As a result of using VISION™, treatment masking and assignment is completely secure and occurs in real-time. VISION™ eliminated the paper tables that could be left lying around or inadvertently unmask the wrong role. Additionally, since the treatment dispenser only sees one treatment group upon randomization, the subject is more likely to receive the correct treatment. If a subject is accidentally given the incorrect treatment, VISION™ mitigates the error by assigning the treatment again according to the randomization set up. When dropouts occur, VISION™ automatically knows what treatment group has been reduced and can automatically reassign it to new enrollees to maintain treatment group ratios.

As mid-study monitoring and data analysis occurs, if a treatment is deemed to be ineffective, VISION™’s randomization module settings can quickly be changed to assign future subjects into the remaining treatment groups. This can save thousands of dollars on the study.

VISION™ makes it possible to handle study-wide randomization across multiple sites. Whenever a new subject is enrolled, regardless of the clinic where the subject is enrolled, VISION™ automatically uses the same formula that would have generated the paper randomization in order to designate the appropriate treatment group. Utilizing study-wide randomization makes it more difficult for any masked personnel to be able to predict treatment assignment.

Additionally, because VISION™ integrates with information located in other eCRFs, its randomization module settings can be used to enter stratification criteria. For example, a study could require each treatment group to be assigned to at least 30 subjects of each gender over 50 years old with diabetes and high blood pressure, 30 subjects of each gender under 50 years old with diabetes and high blood pressure, 30 subjects of each gender and age group with only diabetes, 30 subjects of each gender with only high blood pressure, and 30 subjects of each gender and age group that do not have either condition. VISION™ has the ability to handle these criteria by checking all the stratification criteria and then employing the formula to generate the correct treatment group. Only the treatment group assigned is displayed and all the dosing calculations are automatically done for that treatment. This reduces dosing errors and any other errors that might occur due to treatment group assignment.

Sponsors indicate they are excited about using VISION™’s randomization functionality, and appreciate the cost savings and benefits that it can provide. The principal investigators have always found it a challenge to design studies without or with minimal stratification, and recognize that VISION™ allows them to stratify all the desired criteria. Statisticians recognize that they now have more control over the stratification criteria, which allows for more accurate comparisons between treatment groups. Statistically speaking, when stratification criteria is not applied correctly during randomization, one treatment group could contain insufficient subjects to meet the stratification criteria at the end of the study and could interfere will proper analysis, and therefore, study integrity.

About Prelude Dynamics & VISION™

Prelude Dynamics is a global provider of customized web-based software systems for data collection, analysis and management of clinical trials, studies and registries. We streamline eClinical operations through our unique and innovative VISION™ software system, which allows us to rapidly configure data collection solutions for pharmaceutical, CRO, medical device, animal health, and university organizations.

Prelude Dynamics Publishes Client Case Study Featuring Great Ape Heart Project

AUSTIN, TX – March 23, 2015 – Prelude Dynamics, a global provider of web-based software systems for data collection, analysis and management, announced today the publication of a new case study featuring the Great Ape Heart Project (GAHP) based at Zoo Atlanta. The case study details the challenges GAHP faced in their quest to understand the underlying causes of heart disease in great apes and identify disease patterns across a global population of apes.

GAHP addresses a critical need within the zoo community to investigate and understand cardiovascular disease in great apes. A main GAHP goal is a centralized database that aids in the analysis of cardiac data and coordination of cardiac-related research, while improving communication among institutions where apes are cared for and housed around the globe.

Prelude Dynamics was selected to build the GAHP cardiac health registry to meet the challenge of collecting and coordinating world-wide data and to fulfill the need for a viable technology-based solution. Already known for an established EDC system, VISION™, and exceptional service and support in the animal health industry, Prelude was the obvious best candidate.

“Prelude had a deeper understanding of our needs than other companies that have not dealt with zoos or the veterinary community,” said Dr. Marietta Dindo Danforth, GAHP’s Project & Database Manager. Danforth went on to share, “The most immediate and valuable solution that VISION™ provides us is the ability to […] access our complete cardiac medical records from any place at any time…”

For more information about the Great Ape Heart Project based at Zoo Atlanta and their decision to use Prelude Dynamics; VISION™ as their online registry, read the case study today: Great Ape Heart Project Case Study

About Prelude Dynamics

Prelude Dynamics is an industry leader at providing innovative software-as-a-service technology solutions for clinical trials across the globe. The company’s flagship product, VISION, offers secure and configurable data capture and information awareness tools for the advancement of human and animal health, compliant with FDA/CVM and EMEA regulations. VISION™ facilitates real-time data collection, querying, cleaning, reporting, and analysis all based on the needs of the researchers. The company was established in 2003 with a goal to speed the study process, improve data quality, and facilitate easy data entry through automation.

Contact

Jim Pedzinski – VP of Business Development
jpedzinski[at]preludedynamics.com – 512-476-5100 ext. 210

VISION™ Reduces Clinical Timelines for Pivotal Aratana Study

AUSTIN, TX – February 9, 2015 – Aratana Therapeutics, Inc. (PETX) announced on December 18th the positive, statistically-significant (p < 0.05) results from its pivotal field study of AT-001 (Grapiprant), the company’s innovative drug for treating pain in dogs with osteoarthritis. This was just the latest pivotal clinical trial to use the VISION™ electronic data capture system, developed by Austin-based Prelude Dynamics and it was key to the conduct of the study.

“Using VISION™ to monitor the data in real-time, search data and create reports within the system to monitor progress was definitely instrumental in making the study run smoothly and efficiently,”

said Dr. Johnny Jacobsen, Chief Operating Officer at AlcheraBio LLC, the clinical research organization that managed the study. Study sites and AlcheraBio personnel find VISION™ intuitive and easy to navigate.

“VISION’s strength is its ability to automate the intricacies of the study for complex protocols beyond what sponsors typically expect,”

said Prelude Dynamics CTO, Dr. Alicia Browner. VISION™ has a library of customizable features that allow for these expedited timelines. For Aratana’s AT-003 study, assessments could be selectively hidden from view of the assessor when complete; integrated inventory-tracking streamlines the drug reconciliation process; Con Meds and AEs are cross-referenced; complex cross-form constraints and calculations are easily configured. All information is easily accessible directly on the page that holds the data, such as queries, notes-to-file, errors, and audit trail. Real-time remote access to data enables Monitors to query specific data, automatically notifying the site to review and respond. This built-in exchange allows data reviews to occur much closer to the actual data collection time.

“The fact that Aratana was able to lock the database and release their results simultaneously shows the quality of the data they collected and analyzed using VISION,”

said Richard Tieken, Prelude Dynamics CEO. This allows for studies to consistently close out months ahead of schedule. Where it may have taken months to clean and lock the entire data set, with VISION™ it takes days. Prelude’s services have benefited sponsors in hundreds of human, companion animal, and food animal clinical trials in all Phases, across 25 countries, in multiple languages with hundreds of sites and thousands of patients.

Prelude Dynamics Named in New GIA Report on E-Clinical Trial Technology Driven by Emphasis on Operational Excellence

SAN JOSE, CA (PRWEB) – February 4, 2015 – Demand for e-Clinical trial technologies is on the rise, spurred by the mounting pressure on biotech and pharmaceutical companies, medical device manufacturers, and contract research organizations (CROs) to accelerate the processes for clinical studies, regulatory approval, and commercialization of drugs. Stringent regulations mandating standardization of clinical study data and the acceptance of electronic submissions of clinical data by regulatory authorities are driving the need for advanced, user-friendly on-site data collection tools and eClinical systems. The growing trend towards globalization and outsourcing of the drug development process, coupled with the increasing complexity of Phase IV or post-marketing studies, are providing opportunities for clinical trial management solutions. Cloud computing is rapidly growing in popularity as a preferred model for delivery of e-clinical trial solutions. Cost advantages, flexibility, and functionality are key benefits driving customer acceptance of cloud solutions. Open source technologies are emerging into a preferred platform, given their cost advantages and interoperability benefits over proprietary platforms.

As stated by the new market research report on E-Clinical Trial Technologies, North America remains the most prominent market worldwide, supported by the strict legislative and regulatory atmosphere, and escalating clinical trial expenditure. Asia-Pacific ranks as the fastest growing market with a CAGR of 13.6% over the analysis period. Developing economies with large heterogeneous patient pools and high diseases prevalence are attractive locations for conducting clinical trials. Electronic Data Capture represents the largest technology sector, supported by the rapid replacement of the traditional paper based systems. Despite numerous time-saving and cost advantages, EDC adoption remains relatively low in Phase I clinical trials due to high purchase and implementation costs. Phase III clinical trials provide the bulk of sales revenue of EDC solutions. Tablet-based EDCs are gaining in popularity due to the portability benefits offered.

The research report titled “E-Clinical Trial Technologies: A Global Strategic Business Report” announced by Global Industry Analysts Inc., provides a comprehensive review of market trends, issues, growth drivers, recent mergers and acquisitions, strategic industry activities, and profiles of major and niche companies worldwide. The research report provides market estimates and projections in US$ Million for major geographic markets including the United States, Canada, Europe, Asia-Pacific (including Japan), and Rest of World. The global market is analyzed by major E-Clinical Trial Technologies, namely Electronic Data Capture (EDC), Clinical Trial Management System (CTMS), Electronic Patient Reported Outcome (ePRO), and Randomization and Trial Supply Management (RTSM) Systems. The EDC segment is further analyzed by Clinical Trial Phase (Phase I to Phase IV), and CTMS segment by Delivery Mode (Web-based CTMS, Cloud-based CTMS, and On-Premise CTMS).