At the heart of the CTMS Product is our Project Management module. Customers can monitor the progress of an individual or multiple projects. With the help of our uniquely relevant reports and dashboards, Project Managers can have a birds-eye- view of the project(s). They can drill down into the details if needed.
Project Managers can maintain calendars for project tasks or resources. Holidays, weekends and working hours can be mapped on the calendars. Completion status can also be mapped onto the calendar to visually monitor the project progress.
Project Milestones Tracking
Milestone tracking is key for success or failure of any project. It has significant impact on the project profitability. Using our system, Project Managers can map the milestones on the project calendar. With reminders and alerts feature, all the milestones get adequate attention from the project team members.
Using the calendar features, Project Managers can keep track of various training activities for project teams or system users. Training progress and completion status can be tracked and reported.
Operations Managers can maximize the resource utilization across multiple projects/trials, without overloading critical resources. They can assign roles and responsibilities for individual resources, maintain start/stop dates on the project(s) and manage site level authorizations.
Investigation Sites play a pivotal role in the success of any clinical trial. It is here, the real action takes place. Most of the resources from CROs or SMOs are engaged with the Investigation Sites. Our Sites Operation Management module helps in effectively managing and monitoring the Site Operations.
Site Registry Management & Sites Selection
Your Operations Team can maintain a central registry of all the Investigation Sites. If you are using our IRT/IWRS system for any trial, the performance statistics are automatically reflected against each site. This makes it easy for operations team to make site selection decisions for new projects.
Sites Visit Management
Sites visit management is an essential aspect, under risk based monitoring. From a regulatory perspective, it is important to monitor the protocol deviations. Our Sites Visit Management module helps on-site or centralized monitoring of the sites, through automatic and manual alerts. CRA can submit Trip reports for approval of their managers.
With clinical trials costs forming significant percentage of the overall drug discovery phase, it is imperative that all the stakeholders have a tight control on the budgets for each and every study. Our Budgeting & Forecasting module helps in forecasting the project budgets and monitor the budgets with actuals. It helps in financial planning of the cash flow. Budget revisions can be performed and amendments to the revisions can be visualized easily.
Our Revenue and Expenditure forecast process aids in better foresight into the financial viability of the study/project. It helps Management to select projects that are profitable.
Changing business requirements may result in revision to the original budgets. Our tools helps in budget revisions with version control.
One of the key result areas for the Project Managers is to maintain positive cash flow. With the help of our Finance Management modules, Project Managers can plan the receivables and payables. They can achieve the highest levels of business performance and financial excellence.
The Finance Management module helps in tracking periodical or milestone based payment schedule. Based on the project deliverables or time bound progress, they can issue payment advice, which can be used by Finance department to make the necessary payments. Payment details can also be captured against each payment advice, to provide a complete visibility to all stakeholders.
This feature enables the Project Managers to track all of the project receivables based on milestone completions or periodic progress of the project, helping them to raise payment advice to Customers. Finance departments can act on these advises and raise timely invoices. Once the payment is received, the status can be updated against each of the payment advise.
Our Vendor Management module helps manage the entire vendor lifecycle right from Vendor registration, evaluations, contact management, payments and vendor evaluations. Integration with the Finance Module helps track the payment statistics against the services rendered.
The system maintains a Master List of all Vendors and the contracts/agreements executed with them. It also helps track the milestone based invoices received from the vendors and the payment status.
As per regulatory requirements, it is necessary to audit all vendors who participated in a clinical trial. By using our system, we can schedule vendor audits, record audit observations and maintain each vendor’s qualification status.
Vendor Services Tracking
Track services procured for each project or across the projects. With the assistance of the tool, there is no room for delays in payments to the vendor. After all satisfied vendors provide satisfactory solutions.
Stakeholders involved in Clinical Trials are required to maintain and preserve different types of documents, such as regulatory, contractual and project related. Our Document Management module allows you to manage the lifecycle of these documents.
Using our system, the Operations or Project Teams can list all the documents to be maintained, including their validity dates. Document expiry dates can trigger alerts to take necessary actions. User based authorizations can grant access to rightful candidates. We can also upload the scanned documents against each listing for easy reference. Document hierarchy can be maintained based on the Trial Master File.
We can track important communications with stakeholders for all relevant documents, including the responses from the stakeholders. This helps us not to miss out any mandatory follow-up activities that might impact the project deadlines.
In the context of Clinical Trials Management, in very simple terms, Risk Based Monitoring comprises (a) preventive methods to avoid making a mistake, (b) avoidance methods to detect the potential issues and correct them instantaneously as they occur and (c) corrective methods to work on the mistakes if any, and prevent them from being carried forward.
Monitoring activities should focus on preventing or mitigating important and likely sources of error in the conduct, collection, and reporting of critical data and processes necessary for human subject protection and trial integrity.
Our suite of products are designed keeping in mind the need for preventing errors at the time of data entry. By carefully controlled data entry through dropdown boxes, radio buttons and check-boxes, the data is entry errors can be prevented.
With the help of business rules programming, instantaneously available reports and dashboards, one can detect the potential errors and take necessary actions to avoid the same. Source data verification, screening failure and patient withdrawal trends, AE/SAE reporting features, potential risks can be avoided.
A well-managed CAPA process, notifications/alerts mechanism, errors can be corrected instantaneously Discrepancy handling process in our EDC tool also ensures that the data entry errors are corrected, before they are considered for data analysis.
Success of the clinical trial depends largely on well-designed case report forms, paper or electronic. The FDA guidelines mandating the adoption of eCRF, it is important to ensure that these forms capture the relevant information as per the study guidelines. Our eCRF Management Module, helps design and operate the forms in most efficient way.
With the help of our proprietary CRF builder tool, we can design any type of complex eCRF. Using our business rules manager, we can incorporate form level, field level and study level validations, to ensure data quality and consistency.
Our CRF Manager transaction helps users spend less time in filling the forms. The forms are very easy to handle. Field level and form level audit trails track the changes chronologically with user and date/time stamps. Migration of paper based CRF data into our tool with double data entry features ensure that the data quality is ensured at all times.
The value of accurate data, especially in the context of Clinical Research, need not be overstated. Our Discrepancy Manager lets Investigators, Sponsors and CROs identify conflicts in data, and resolve them quickly and accurately. Our alerts mechanism helps keep a check on the discrepancy handling.
Pharmacovigilance as a topic is attracting lot of traction from general public and government bodies. Patient safety being the fundamental principle at the core of every clinical trial, it is important that the Adverse Events and Serious Adverse Events are reported to all the stakeholder and regulatory bodies immediately and handled appropriately.
Using our Pharmacovigilance module, AE/SAE notifications are sent instantaneously to the CRO/Sponsor representatives and also pre-defined regulatory bodies. All the AE/SAE events are mapped to the visits on a timescale, allowing the monitors to view at what stage of the trial the event occurred. Integrated with the eCRF manager, users can trigger AE/SAE events at any point of the individual study.
Source Data Verification is key aspect in ensuring data quality for better outcomes, though it may appear to be a redundant activity. With volumes of data being generated as part of the study, it is important to have a clear strategy for source data verification. SDV transactions in our system can handle multiple scenarios.
Real Time Availability
eCRFs once entered in our system are instantly available for SDV. CRAs or Data Manages need not wait for batch uploads for SDV, thus enabling better utilization of resources and balancing the workload. User can also enter their comments and raise discrepancies while carrying out SDV transactions.
Full Form or Selective Fields verification
Our system provides flexible options to carryout SDV of the whole form or selective fields of the form depending on the trial requirements. Depending the requirement we can also configure double date entry option for entire form.
Site level source date uploads
With the help of our system, users can scan and upload handwritten notes/prescriptions or printed documents such as lab reports etc. as basic source data for each and every eCRF.
Medical coding helps view the adverse event information and medication administered, in a uniform and consistent manner by medical professionals, especially when the studies are conducted in multi-language in different countries, where the brand names and local nomenclatures differ. Our Medical Coding module helps connecting with latest versions of MedDRA and WHODD dictionaries.
Real-time integration with CRF Manager
As soon as any adverse event or medication is captured in the eCRF, those fields are instantaneously available in the Medical Coding module. There is no need for batch uploads from one system to other. Medical coding experts can evenly distribute their workload, instead of accumulating the work till completion of all the forms.
Auto and Manual Coding
Depending on the clarity of the data entered, our Medical Coding module facilitates auto-coding to the extent possible. The system uses latest search algorithms to do the data match. Those which are left out can be manually coded.
Data Quality is a major priority in clinical trial data management. Customers prefer to achieve this within budget and timelines. Our EDC solution emphasizes high degree of data integrity, transparency and accountability from Study Set up phase till database lock. Our solution is flexible and user friendly.
Data Standards & Dataset Exports
Our solution adhere to the International CDISC standards, ensuring consistent data uploads for statistical analysis. Our data export feature fosters standard and customizable dataset exports in .CSV and .XLS format. Project Managers can download the data any time during the study, for intermediate checks.
Casebooks with Bookmarks/Hyperlinks
Project Managers and CRAs can download the casebooks anytime during the study, in PDF format with hyperlinks and bookmarks.
The Sites Handling modules support all processes related to managing sites and monitor their performance.
Sites Registration process helps enroll the sites and site personnel information including contact details, for ease of site selection during the planning phase of a Clinical Study. Sites once enrolled into a study can be activated, deactivated or reactivated depending on the situation.
Site Specific Access
CRAs and Data Managers can be granted selective access depending on their scope of control. This helps in clear cut accountability, while ensuring confidentiality beyond ones reach.
Our patient handling module helps manage patient related activities very effectively and efficiently. Different patient statuses such as, enrolled, randomized, withdrawn, un-blinded and completed, can be monitored at the click of a button. This helps in ensuring patients study completion targets.
We can tailor the patient visits to suit the requirements of the study. The system can allow visit skips, unscheduled visits and delay tolerance depending on the study design. Each visit can have a unique set up.
A quick and easy un-blind option. That is exactly what doctors need to know in case of an emergency. Our system eliminates the need for time consuming procedures in these situations while maintaining the integrity of the Clinical Trial.
Intuitive process flow
Handling patient visits has never been this easy. All activities in any given visit can be performed in a sequentially guided process, ensuring completion of mandatory activities before moving on to the next visit.
Our Drug Logistics Handling module enables the Sponsors and CROs to have complete control of the investigational products across the supply chain. It nsures the regulatory requirements like stock retention, drug accountability. Random drug allocation (Randomization) based on a set of business rules is feasible through our tool.
Flexible Stock Management System
Take complete control over stock supply strategy. Position the stock at any location based on the demand. Manage stock transfers between warehouses and from warehouse to the sites. You can also return the unused stocks at the sites to the warehouse. Our stock expiry check feature ensures that no expired stock reaches your patients.
Depending the stock levels at the Sites, automated or manual shipment requests can be raised to ensure adequate stocks are available at the investigation sites. Our system even lets you cancel shipments while they’re in transit.
Stock adjustments transaction helps manage different types of stock at any given site. For example Active usable stock can be moved to quarantine or rejected stock depending on the physical status of the stock. Our system can track the reasons for changing stock from one type to another. This feature is especially useful to analyze the reasons behind stock adjustments.
Reports and Analytics offer the users up-to- date online reports in their individual portal based on their authorizations. These reports are created keeping in view the needs of various users involved in clinical trials.
All relevant information is clearly and precisely presented through our comprehensive reports and analytics. All reports are available for download for off line use.
|Sites Handling Reports||Patients Handling Reports||Stock Reports|
Sites Summary Report
Patients Summary Report
Overall Stock Status
Sites Detailed Report
Patients Detailed Report
Site Stock Summary
Individual Patient Report
Site Stock Detailed
Biometric information is a fool-proof way of representing volunteer details enables validation of cross-study participation. It also helps in identifying subjects easily during Check-In and Check-out activity.
Biometric Registration and Enrollments
Volunteer registration is directly done with all the demographic details and Biometric information. The tool facilitates subject ID card generation and helps create a pool of eligible volunteers.
Barcode scans on Patient Wristbands
Barcodes on the Patient ID card helps to pull out the volunteer information from the system making patient handling and sample management easier.
This tool allows you to effectively manage associated lab data to improve lab efficiency. The system is designed to ease the integration of lab data into the eCRF.
Lab Data Module
The tool holds organization details of labs in a virtual setup that is specific to the study requirements. Parameters and reference ranges are configured with the labs and their corresponding lab tests.
Lab Data Integration
Every single data field in the transactional file format provided by the labs is mapped to the database and edit checks can be designed to ensure data is validated against pre-defined reference ranges.
Reliable tracking, organization and reporting of samples is done as they make their way through the scientific process that leads to influential therapeutic decisions. It also provides a flexible way to quickly identify the current storage location of a sample
Sample Movement Tracking
The dispatch and receive sample transactions keeps a check on the movement of the samples across multiple storage locations in its lifecycle thereby maintaining the integrity of the data and its results.
Barcode Scan for Vacutainers and Aliquots
The tool manages the accountability and validation of all biological samples including its segregated samples through barcode scans and generation of unique IDs for easy tracking.
Virtual storage locations are an exact representation of the samples available in the physical storage. The user can allocate available storage units to each of the segregated sample.