Generic medicines ensure affordability & availability and acts as a competitive alternative to branded medicines. Pharmaceutical companies that are into Generics business perform BABE studies to establish Bio-Equivalence and Bio-Availability parameters between Test and Reference drugs. Subjects who are healthy volunteer participate in BABE Studies after appropriate consent and screening evaluation procedures. Study constitutes of different phases like Clinical, Bio-Analytical and Data Management for regulatory submission. Stake-holders across and within organizations participate right from the study initiation till study completion. This would include Sponsors, CRO’s Subjects, IEC’s and Regulatory. Since they are geographically distributed a solution platform is required for all the stake-holders to communicate seamlessly.

Regulatory guidelines define that Bio-Equivalence and Bio-Availability studies be conducted in an ethical, compliant and procedure-driven manner. Aspects like subject safety, data integrity and optimization form critical parameters of these studies. A seamless data management platform is required so that various stake-holders in the process have access to real-time data for decision making and hence improve the quality of the study conduct process for desirable results. Pharmaceutical companies and Clinical research organizations look at efficient and complaint drug development models to have faster access to markets. Regulatory deviations are very expensive in terms of reputation, cost and effort. System driven Study management process is the key for consistent quality delivery of Clinical Studies.

Features

• Subject Screening

Biometric based volunteer management forms an integral part of the subject screening process to ensure that the subjects are enrolled in the study as per regulatory and protocol requirements.

• Study design

The entire study design is automated and system driven to ensure that it is as per the protocol specification. Based on the study design the electronic data capture forms and study barcodes are generated automatically by the solution.

• E-CPU Activities

Activities like Dosing, Sample Collection, Sample Separation, Vitals and Meals are driven by barcode-based data capture to ensure data integrity and compliance.

• Reporting

Electronic data captured right through volunteer registration, screening and study management can be imported from the solution for subsequent activities like E-CTD and CDISC dataset creation.

Pharmaceutical companies are focusing towards conducting compliant, secure, efficient and faster Clinical Trials to ensure first to market privilege. Clinical trials involve multiple stake-holders including Sponsors, Clinical Research Organizations, Ethics Committee, Hospitals, Physicians and Subjects. With multiple stake-holders in picture, who are geographically distributed, seamless access to real-time data would be critical to ensure quality service delivery of the trial in progress. In this scenario, data integrity, compliance, turnaround time and decision making becomes critical for the success of the trial. From the ethical perspective patient recruitment, retention and subject safety are important parameters to be considered in Clinical Trials and hence a unified platform becomes inevitable for desirable results.

NeoEDC & CDM is a solution platform to run smart, efficient, compliant and optimized Clinical Trials. The solution leverages IOT (Internet of Things) to ensure compliance, security, efficiency, and faster Clinical Trials. Based on the protocol information the entire study design & plan is generated automatically and activities like screening, randomization, subject visits and monitoring are tracked. Un-scheduled visits are also managed and appropriate reporting mechanisms are in place. The solution has a user-friendly and dynamic E-CRF & robust CDM engine to generate data capture forms and validation rules thus supporting various Clinical Study designs. Dedicated discrepancy management module ensures that any data discrepancies from sites are addressed in a timely manner and thus improving the quality and TAT of the studies being conducted. Patient diaries make sure that the subject dropouts are avoided and successful completion the studies. Hence the solution strikes a perfect balance towards addressing regulatory requirements, integrity of the study and ease of study conduct.

The salient features are as provided below:

Features

• Study Design

Dynamic solution platform that supports varied study designs and data management requirements. Scalable solution platform enabling end user to generate relevant data capture forms and validation rules.

• Subject Visits

Protocol driven subject visit planning and scheduling module ensures that subject visit-based data is captured accurately and timely manner. Supports both scheduled visits and un-scheduled subject visits.

• Data Management

Conduct of Clinical Trials happens in geographically distributed locations and hence information collation should happen seamlessly. The robust data management platform ensures data integrity and protocol adherence.

• Discrepancy Management

Protocol deviations alerts across sites are implicitly triggered and tracked until closure. Saves turnaround time in resolving discrepancies related to data thus having a positive impact on overall Study management procedures.

• Data Export

Configurable Clinical Data reporting module provides a user-friendly approach to extract data in PDF and Excel formats. Integration with 3rd party solution can also be configured.

Animal Studies have complex procedures involving Acclimatization, Randomization, Grouping, Data capture and Reporting. Data capture would involve acquiring instrument data, for instance, from weighing balances and clinical pathology instruments. Study protocol defines the frequency of data capture over a period of time and hence a protocol specific data capture schedule to be defined and tracked. Processes to manage protocol amendments and deviation should be in place for any study design changes that may happen during the course of the study. Automating these processes would improve compliance, data integrity and turnaround time thus ensuring a seamless conduct of the study in progress.

NeoTOX is a unified electronic data capture and management platform built to manage toxicology studies in an efficient and compliant manner. A dynamic platform supporting various types of study design and protocol requirements to ensure seamless management of study procedures. Protocol specific experimental design and observation design can be configured to support study schedule-based data capture. Direct integration of instruments ensures data integrity and resource optimization thus avoiding manual intervention that can be error prone. Critical procedures like Acclimatization, Randomization and Study grouping are automated and hence system driven without manual intervention. Access to real-time data enables timely decision making, for instance, in case of animal mortality and plan subsequent process to follow. Protocol amendments are managed and tracked with appropriate approvals before including in the study schedule. Implicit and Explicit deviations are raised and tracked until closure. Reporting and data extraction features are an integral part of the solution.

The salient features are as provided below:

Features

• Study Design

: Protocol based study experimental design and observation design are defined in the system. Study schedule is generated based on protocol requirements for tracking and data management.

• Acclimatization

: Process involving animal reference number generation, acclimatization related data capture, randomization and animal grouping are automated with optimized in-built algorithms. Integrated with Animal permanent identification process.

• In-Life Phase

Conduct of Clinical Trials happens in geographically distributed locations and hence information collation should happen seamlessly. The robust data management platform ensures data integrity and protocol adherence.Protocol driven In-Life phase data capture procedures ensures Study information is captured in a compliant and user-friendly manner. Solution supports both scheduled and un-scheduled data capture modes with relevant frequency-based user alerts. Formula based calculations between fields can be defined in the solution. Deviation related to data capture are raised appropriately and tracked until closure.

• Instrument integration

Data from instruments like weighing balances, clinical pathology instruments are directly captured into the solution without any manual intervention to ensure compliance and data integrity.

• Reporting

Data collected throughout the study can extracted as PDF and Excel reports for Statistical analysis. Integrated with Statistical analysis tools can also be configured in the solution.