Case Study Neurology (Anxiety)
Geography: N/A
Type Service: N/A
Background/Client Requirement:
A prominent Nano therapeutics company, renowned for its creation in innovative products in specific therapeutic areas such as Pain management, Supportive care, CNS Disorders, Immunomodulators collaborated with Techsol Lifesciences to conduct clinical trial for their Cannabidiol oral solution ensuring compliance with principles of good clinical practice in accordance with the health authority regulations.
Project Objectives:
The aim was to conduct a multicenter Phase-III clinical trial across India to enroll patients with mild to moderate anxiety disorders and evaluate the Efficacy, Safety and Pharmacokinetics of Cannabidiol oral solution compared to a matching Placebo for the treatment of mild to moderate anxiety disorders.
The study objectives included:
- Primary Objectives: To assess the changes in the Generalized Anxiety Disorder Scale (GAD-7) and Hamilton Rating Scale for Anxiety (HAM-A) scores at the end of treatment (Visit 9, Week 11) compared to baseline for evaluating mild to moderate anxiety disorders.
- Secondary Objectives: To evaluate changes in scores for the Clinical Global Impression-Improvement (CGI-I), Clinical Global Impression-Severity (CGI-S), Patient Health Questionnaire-9 (PHQ-9), and Pittsburgh Sleep Quality Index (PSQI) at the end of treatment compared to baseline.
Challenges:
- EDC vendor on-boarding process
- Study database design: Complex study design requirements, combined with tight timelines for study go-live made database design critical.
- Data Quality: Ensuring the quality and reliability of the data was crucial. The high volume of data increased risk of low-quality or irrelevant information, which impacts decision-making.
- High Volume of Data: Sorting through a large volume of data was overwhelming, leading to system performance issues and difficulty in identifying relevant insights for day-to-day clinical operations.
Techsol Solution/Approach:
- As per the client’s requirement, we have identified and selected a vendor capable of providing EDC solutions within very short timeframe, meeting sponsor’s stringent timelines in conducting clinical study.
- To ensure the highest quality and regulatory compliance, we validated the EDC solution in accordance with 21 CFR Part 11 guidelines for computer system validation.
- Our data management team design the CRF in accordance with the study protocol and obtained client approval. Following approval, our data management team worked closely and rigorously with the vendor’s database team to design and build study in EDC solution, adhering to industry best standards (CDISC).
- Techsol provided various artifacts like eCRF data entry guidelines, role-based training, and documentation for EDC applications users, ensuring accurate data capture the study sites.
- Our CDM team has initiated various activities related to data cleaning and thrived hard to achieve quality. This included close collaboration with site personnel to ensure accurate data entry as per source documentation through regular follow-ups. Additional training and guidelines were provided to site users as needed.
- In line with our SOP’s, we ensured timely responses for the discrepancies raised by data management team. To facilitate this, we conducted weekly meetings with all key business stakeholders to address any hurdles in achieving our target.
- A dedicated QC team, including designated medical monitor, lead data management personal to perform 100% data review for critical and non-critical study data points.
- CDM team worked closely with vendor in identifying the system bottlenecks and optimized the data for better performance
- Developed complex and custom dashboards and reports to support the Clinical data managers, Investigators, site coordinators, and research associates, enabling more efficient and accurate day-to-day activities.
Project Achievements:
Techsol has consistently delivered high-quality data and managed end-to-end processes by involving the right stakeholders to achieve key milestones.
- Comprehensive Documentation: The team successfully designed CRFs, aCRF’s, reports, metadata, while providing valuable inputs to the DB team to ensure accurate clinical data recording. This included detailed documentation of the methodology, data sources, analysis, and conclusions drawn.
- Data cleaning: Unlike the traditional approach where CDM reviews data only after source data verification by site monitors, Techsol adopted a proactive approach by initiating data cleaning as soon as data is entered by the site. This supported risk-based monitoring, allowing monitors to address CDM issues prior to their next site visit. This approach resulted in more efficient data monitoring and streamlined data cleaning. As a result, Techsol’s biostatisticians were able to confidently transfer semi-clean monthly SDTM datasets. Additionally, CDM provided transparent updates to the Sponsor’s clinical operations team through weekly and ad-hoc reports to ensure that resources were focused where most needed.
- Data Quality: Prior to final QA assessment, data underwent rigorous review specialist QC team including critical and non–critical data points essential for the conduct of the study. This meticulous review process ensured that data points were missed during review, enabling Techsol to achieve 100% data quality.
The Outcome:
Techsol’s continued support in clinical data evaluation, coupled with industry best practices, has been instrumental in the partnership’s success. This achievement is attributed to the collaboration between experienced resources and the client’s QA team. By leveraging Techsol’s expertise, multiple documents are delivered swiftly, meeting expedited timelines without compromising quality. This streamlined approach ensures compliance with data cleaning standards while maximizing efficiency.