Clinical Trial Services & Solutions
Pharma companies are regularly challenged by the limited opportunities for blockbuster drugs and impending expiry of major patents. Moreover, they need to personalize medicine, meet data safety concerns, and comply with the evolving regulations. Applying the right methodology to anticipate and overcome the challenges arising during the course of clinical trials is the only way to increase project success.
PureSoftware specialized team helps in maximizing the data generated from clinical trial to improve efficiency, minimize the risk and reduce the overall development costs. We also ensure drug safety and offer all components required for a compliant and effective pharmacovigilance system.
Clinical Data Management
Clinical Data Management is a critical phase in clinical research, and data integrity is of paramount importance. We use technology to ensure the integrity of the clinical data, which improves compliance with the trial protocol as well as patient safety. We achieve this by automating certain processes and reducing manual intervention. This has resulted in a considerable increase in efficiency and reduction in time.
Few studies have been handled across various therapeutic areas as below:
Cardiology | Vaccines | Infectious diseases | Quality of life studies | Oncology | Neurology | Nephrology | Woman Health | Respiratory | Dermatology | Endocrinology
We are specialized in each step of the clinical data management process:
- Protocol Review
- CRF Design and Development
- Clinical Database Design and Development
- Edit Check Programming and Testing
- Risk-Based Monitoring Strategies
- Data Management Plan Development
- Data Management Trial Master File Set-Up and Maintenance
- 24/7 EDC Helpdesk
- CRF Completion Guidelines (CCG) Development
- Subject Diary Design and Development
- EDC Access Administration
- EDC System Training for Sites and Monitors
- Development of Custom Status Reports
- Optimal Technology Solution Recommendation
- Data Review and Validation
- Query Reconciliation
- Import, Integration, and Cleaning of Electronic Data (Lab, ECG, PK, Diary etc.)
- Independent QC Review
- Adverse Event, Concomitant Medication, and Medical History Coding
- SAE Reconciliation
- Database Lock
- Study Archival
In today’s scenario, less than 10% of new compounds have reached the market. The advanced biostatistics services and efficient clinical solutions are needed for reducing the costs and risks and improving the quality of submissions.
Our expert biostatisticians offer innovative clinical solutions for clinical research and apply statistical concepts in designing and executing efficient clinical trials. We work across every phase of drug development and therapeutic areas. Our experts are industry leaders and have deep knowledge of global regulatory requirements, statistical methodology, and experimental design for helping in designing your trial for decision making.
Our team has a deep understanding of the science of disease and compounds, and able to demonstrate the efficacy of the study drug by providing valuable upfront study design and comprehensive planning assistance that:
- Reduces risk of compromised timelines and errors
- Production of audit-ready tables, listings, and figures
- A centralized computing platform which unifies global biostatisticians and programmers, resulting in increased productivity, saved time and enhanced data security
- Comprehensive methods reports are developed for describing planned and exploratory analyses
- New drug application (NDA) submission-ready data is delivered in the format of Clinical Data Interchange Standards Consortium (CDISC)
- Collaboration with medical writers and clinical scientists in ensuring appropriate interpretation of quantitative results
We ensure complete, concise reporting through:
- Integrated submissions of statistical sections
- Data and safety monitoring board (DSMB) output, provisional analysis and an investigational new drug (IND) safety updates
- Accelerates decision making
- Support for manuscripts and abstract
- Strategies such as the International Conference on Harmonization (ICH)-compliant
Our statistical programming experts are working closely with our bio statisticians. We have the ability to turn an uninterpretable data into meaningful data for improving patient safety, making informed decisions, getting drugs, and demonstrating drug efficacy to market faster.
PureSoftware statistical programmers are industry leaders in offering validated results to submission-ready deliverables and clinical study reports.
Our expert programmers have detailed knowledge of all therapeutic areas across the drug development spectrum. PureSoftware provides Statistical Programming Services that include
- CDISC and ADaM Submission-ready Dataset Development and Quality Control for Submission Compliance
- Analysis Dataset Development and Quality Control
- Analysis Dataset Development and Quality Control for Integrated Summaries of Safety (ISS) and Integrated Summaries of Efficacy (ISE))
- Tables, Listings, and Figures Development and Quality Control
- Tables, Listings, and Figures Development and Quality Control for ISS and ISE
- Interim Analysis Support
- Annual Clinical Trial Safety Updates
- Data Monitoring Committee (DMC), Safety Committee and Endpoint Committee Support
The complexities involved in regulatory safety reporting necessitates proficiency to ensure quick access to intelligent data. The capture and analysis of safety data is critical in clinical trial management, as trials ultimately must demonstrate safety as well as efficacy.
PureSoftware provides Pharmacovigilance services that allow long-term success. Our consultants address the issues related to drug safety and process consistency, like the new compliance requirements and can integrate safety data from dissimilar sources.
Our team has a vast knowledge of product safety and pharmacovigilance services in clinical research including but not limited to:
- Monthly compliance and status reporting
- Literature reviews and medical narratives
- MedDRA Coding
- 24×7 call centre equipped with Oracle AERS software
- Preparation of ICSR and PSURs
- Adverse event tracking
- Signal detection and trend analysis
- Regulatory submission
- Med Watch/CIOMS form generation