Study Start-up

Collaborate effectively and speed up time to site activation.

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Study Start-up

Cloudbyz built the Study Start-up solution on the Salesforce Cloud platform to accelerate study start-up and activation. The solution provides the ability to: track site performance metrics, profile, perform feasibility surveys and via Portal, provides a centralized location for accessing and sharing all study-level information. Registration process for CRA and investigators to participate in the study and cases for inquiry management. Chatter based collaboration forum to discuss and collaborate around study between investigators and study coordinators. Directories with contact information for all study personnel including external vendors. Study library serves as a repository for study-related training tools and documents. Study news updates and alerts. Supply order/reorder forms.

Product Features

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Study Set Up

Set up and visualize studies according to protocol requirements and easily access details such as phase, type, therapeutic area, indication, outcomes, eligibility, etc. Set up and track protocols and amendments.

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Regulatory and Ethics Approvals

Track ethical and regulatory approvals and access IRB-approved content from one place. Organize the content by approval and expiry dates. Store the content at the site level or the study-specific level based on the approval type.

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Budgeting

Set up and allocate study level and site level budgets for Start Up activities. Use templates to define budgets for site-specific costs and associated costs such as staffing, patient recruitment & retention, outsourcing, vendor selection & management. Generate metrics to compare spending and return on investment between various sites and studies.

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Site Feasibility

Create the study feasibility templates within the system. Modify and customize the templates for each study and site. Send feasibility surveys and record responses in real-time within the system. Sites can use fillable forms for quick and easy completion.

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Site Engagement

Deliver content and services to clinical research sites through the investigator portal. Provide documents to all the sites through the system to keep the sites informed and engaged. Design and send the selection, non-selection, and activation letters directly from the system.

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Essential Document Collection and Management

Make study level and site level essential document checklist templates and apply these templates to various studies based on the study types. Collect, track, and save the essential documents directly into the eTMF. Create site activation checklists and apply them to each site individually.

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Study Calendar

Create personalized calendars for all important milestones and tasks across the studies. Plan, budget and manage your resources for all upcoming studies.

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Milestones and Tasks

Track various study start up milestones and the tasks required to complete these milestones. Allocate time and budget resources to each milestone and gain full granular oversight over each start up activity.

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Reports and Dashboards

Track metrics with customized reports and dashboards. Create these reports with a point and click configuration. Powerful graphs and analytics present critical site and study metrics that significantly increase effectiveness for current and future trials.

Feasibility Assessment

Evaluate the responses with the help of various dashboards and reports. Save each site’s credentials for future reference and use. Generate and save various feasibility metrics.

Study Start-up

Collaborate effectively and speed up time to site activation.

Study Start-up