Due to changing regulations as well as a cost sensitive and competitive market, globally recognized Clinical Research Organizations (CRO) are faced with certain challenges. This includes providing flexible, cost-effective, and comprehensive clinical trial management services with innovative solutions. Additionally, an integrated platform comprising clinical trial related transactional systems is deployed as well.
CROs are also facing data standard complexities, because data is collected from various sources as a standalone system. This creates additional challenges in aggregating and synchronizing the transactional data.
With cost optimization pressures and faster turn-around on clinical trials, CROs are looking towards outsourcing their IT footprint and some of the business functional services.
We partner with CROs to help them manage comprehensive clinical research trials and extend support across various stages of clinical trial. Our competitive back office services facilitate improved trial management with informed decision, resulting in quality outcomes within budget and timely submission for drug approval.
Our team of experts understands clinical trial applications. We partner with various clinical trial software vendors to provide streamlined and seamless functional services, irrespective of systems.
The demand for CRO services is driven by small and medium sized Pharma companies, as 60-80% of the intellectual property (IP) resides within these companies. Therefore, CROs need to build solutions that are low in cost with minimal infrastructure footprint to generate quick RoI.
Larger Pharma companies are focusing on long-term strategic alliances or one-stop-shops boasting broad service offerings that include non-traditional capabilities such as health economics and outcomes research (HEOR), market access, and Pharmacovigilance. However, large Pharma companies will develop alliances with CROs that have end-to-end capabilities (IT+ Science).
We possess deep understanding of the end-to-end clinical trial process. We provide several innovative services in technology as well as business functional areas, which helps CROs reduce their IT investments with faster, accurate, and effective outcomes:
- Strategic Consulting
- eClinical and transformational consulting and unique transformation solutions aimed at enabling CROs offer cost competitive and improved services to their sponsors
- Build executable strategy with extensive industry knowledge, analysis, and insight
- Business Functional Services
- Innovation driven, transformation leading to Improved productivity and streamlined business/technical operations
- Project Management
- Patient Recruitment/Enrollment and Engagement
- Site Management
- Data Management
- Biostatics – Programming
- Data Transformation / Standardization
- Safety Services
- Site Monitoring and Payment
- Source Data Verification
- Regulatory Compliance
- Electronic Trial Master File
- Data Analysis and Reporting
- Submission Assembly
- Medical Monitoring and Writing
- Technology Services
- End-to-end eClinical Transactional system platform
- Clinical Data Integration Platform
- Single Sign On - Identify Management
- Market access, patient recruitment, and retention
- Risk Based Monitoring
- Application Support and Maintenance
- Application Development
- System Validation
- Mobility Services
- Laboratory Data Management
Drug development costs an average of over $1 billion and takes 10 to 15 years. However, only 2 out of 10 medicines that reach the market generate desired profit. Any delay in introduction of drug to market costs an average $8 million per day to pharmaceuticals. Data collection for clinical trial is usually manual, paper based, repetitive, and often erroneous. Automated smart device based data collection saves time and money and enhances decision making capabilities.
Smart clinical trials with our Remote Patient Monitoring (RPM) is a next generation cutting-edge solution which focusses on better patient engagement in the healthcare ecosystem. By integrating this solution in their product development proposition, CROs can help Pharma firms in stopping the delay in drug development. The solution makes use of various technology components such as sensory technology in the form of patient wearables, mobility, cloud platforms, and edge analytics to increase the efficiency and success of clinical trials, improve patient engagement, and reduce losses.
The HIPPA compliant RPM solution is built by leveraging our capabilities in Engineering & Research Services in the Medical Devices industry, domain expertise in Life Sciences & Healthcare and our IP’s around Micro-Services, Solution Accelerators, and Data Management & Analytics to touch all the four P’s of the healthcare ecosystem: Pharmaceuticals, Providers, Payers, and most importantly, Patients.
Ecosystem of Partners
Our partnerships bring the relevant technology, industry and domain knowledge together, with tested products, to present a complete joint solution for our customers. By working together with partners, HCLTech augments and supports all solution and technology requirements and ensures that the best results are delivered.