The transition from drug discovery to market-approved drug is complicated, costly, and time-consuming. For biopharma innovators in clinical stage, achieving success depends on one necessary component — how relative clinical trials are managed. Whether a new biologic, a small molecule, or a treatment for an orphan indication, data integrity and accuracy, speed, and regulatory compliance ultimately determine success.
Digital platforms and structured data tools, such as Clival Database, have disrupted how organizations approach clinical trials today. Digital platforms and structured data tools have simplified the processes of collecting, storing, and analyzing clinical data, while remaining compliant and transparent throughout the clinical trial life-cycle. Below, we outline some top considerations when supporting clinical stage biopharma innovators to keep pace with changing landscape of clinical trials.
Know the Clinical Phases
Before you begin investing in enhanced solutions, consider the Clinical Phases in Drug Development. Each phase has its own specific objective, timeframe, and regulatory requirements of coverage.
Phase I – Safety and Dosing
Phase I is the stage of determining safety. The phase typically involves a small number of healthy volunteers or patients, to assess for the safety profile, tolerability, and the ideal dose range for the drug. Safety signals are closely monitored, to determine if the compound advances in the clinical development.
Phase II – Efficacy and Side Effects
Once safety has been confirmed in a smaller sample group, Phase II gathers more evidence about efficacy and continues to look for side effects. Now the sample is larger (on the order of a few hundred patients) and the goal is to see if the drug works as you thought that it would work in the original target population identical to the one that was shown to be safe.
Phase III – Large Scale
This phase will host thousands of patients across centers and countries. Phase III trials will validate efficacy, show the effectiveness of the treatment as compared to other therapies, and collect the data you will need for a regulatory submission for approval. Phase III trials are the largest and the most expensive and complex to coordinate and implement.
Phase IV – Post Marketing
Phase IV trials assess long term effects and rare side effects, using the drug in the “real world” as it pertains to patient outcomes. This phase will allow the drug developers to refine dosage recommendations and safety guidelines.
Although each of the phases of drug development will generate large amounts of data – patient outcomes, biomarker information, etc. – the management of the data itself in all of these drug trial phases is among the biggest challenges within modern biopharma development.
The Challenge: Managing Data Across Clinical Phases
In addition to the types of data we previously discussed being generated during clinical trials, clinical trials generate diverse data types themselves – genetic data, lab results, imaging data, and patient outcomes. Without a structured data management plan (let’s say use an Electronic Medical Record of sorts), it truly is easy to lose time, and accuracy.
Many companies are not dealing with a lack of data but a lack of its accessibility. The challenges arise because teams across clinical sites are often using different tools, formats, or systems. When datasets are inconsistent across sites, this impacts rework, inaccuracies, and delays when submitting data.
Because of these challenges, it is becoming increasingly important to find a solution to clinical trial data. Clinical trial data solutions provide a way to connect all clinical data together in one solution, improving data sharing and analytics across team members and or organizations.
By implementing a solution to gather data, sponsors and CROs team members can have a higher degree of visibility into the study status and the ability to flag issues and risk ahead of time and maintain compliance with international regulations such as ICH-GCP.
The Role of CROs in Clinical Trials
Clinical Trial Organization (CROs) have become a critical and important component of the biopharma ecosystem. CROs manage the biopharma’s study design to patient recruitment, all the way through data and regulatory submissions.
By selecting the right provider, some biopharma companies can grow and scale their operations without developing their own internal infrastructure. Using CROs, biopharma companies can also increase the ability to ensure comparable consistency and quality of trial data across study sites globally.
However, engaging CROs creates another layer of complexity with data, where the sponsor’s must obtain visibility into their CRO’s process and receive real-time access to clinical trial data. This is where clinical trial database platforms assist with maintaining visibility and real-time access of on-going studies.
Why Clinical Trials Database Platforms Are Important.
A clinical trials database platform consolidates all aspects of a clinical trial, from recruiting patients through to the final results of a study. This means that all stakeholders (researchers, CROs, sponsors, and regulators) can be confident that they are working from the same dataset.
Here’s how they help:
- Data Integration – Combines data acquired from labs, EDC systems, and CROs, into a single location.
- Data Standards – Presents information in common formats and controlled vocabularies to minimize variation.
- Regulators Compliance – Datasets are pre-aligned with the FDA, EMA, and ICH-GCP requirements.
- Real Time Monitoring – Allows sites to monitor performance, patient enrollment, and data quality in real time.
- Faster Decision-Making – Lessens delays with manual reporting and errors due to disconnected systems.
In addition, the aforementioned systems help reduce errors or delays related to the submission process. For innovators in clinical stage this translates into faster validation of drug and better use of R&D budgets.
Clival Database: An Authoritative source of Clinical Trials Intelligence
Developing and keeping a reliable source of organized, vetted, and regularly updated classification of clinical trial data is one of the many ways that Clival Database can serve biopharma innovators.
The Clival Database is a structured database to share:
- Global clinical trial records
- CROs and sponsor information
- Tracking studies by phase
- Drug development pipelines
What makes the Clival Database especially relevant is its ability to link trial data with market and regulatory information. It allows users to view data across multiple Clinical Phases, and see trends; for example, what therapeutic areas are receiving the most investment, or what CROs are achieving the most success in studies.
For companies looking to conduct a new trial, the Clival Database can assist with:
- Benchmarking against similar studies
- Pinpointing experienced CRO partners
- Gaining insights into competitive work in a specific indication
- Giving visibility into global study outcomes
When combined with new clinical trial data solutions, the Clival Database enables better study planning, while promoting study execution at a faster pace.
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In what ways clinical trial data solutions are changing the way we work
How Clinical Trial Data Solutions Transform Operations
Traditional spreadsheets and manual tracking isn’t feasible anymore. We are too far removed with the depth of data and regulatory scrutiny.
Modern clinical trial data solutions automate or assist in most of the manual tasks, provide more consistency with increased accuracy, and better transparency. Here’s what modern clinical trial data solutions commonly offer:
- Cohesive Data Access
Their teams will have access to the same dataset even though they may not be sitting next to each other. Everyone in the team, from clinical monitors to data scientists will be using the same data, and that is powerful.
- Automate Validation
Automated systems flag for missing or inconsistent data instantly. Automated systems reduce the amount of queries, and less manual reviews are needed.
- Safeguarding Data Sharing
Sophisticated platforms leverage encryption and permissions per user to secure patient information while promoting collaboration.
- Tying into CRO Systems
Synchronized sponsor and CRO systems for clinical trials, promoting quicker updates and minimizing gaps in communication.
- Data Visualization and Insight
Use of built-in dashboards to help identify trends such as site performance, dropout rates, or adverse event occurrences, so teams can remediate early.
For biopharma innovators, implementing the above technologies is more than a technical transformation—it’s a strategic initiative to strengthen trial performance and defray timelines.
Better Decision-Making with Data
Clinical research-based biopharma innovators wrestle with decisions, largely due to disparate data sources. The difference that leads to better decision-making is dependent on three foundations:
- A reliable clinical trials database platform like Clival Database
- Automated data solutions that allow for real-time analytics
- Cross-functional work between CROs, sponsors, and regulators
In tandem, these technologies allow teams to:
- Identify early signals of trial risks
- Reallocate resources
- Improve adherence to protocol
- Enhance data quality overall
The end result is a more predictable and transparent clinical process.
The Future of Clinical Trials
Digital transformation is affecting all parts of the biopharma industry. Decentralized trials, artificial intelligence-based patient selection, and integration of real-world data have quickly turned into industry norms.
Clinical trial data solutions will also be heavily based on artificial intelligence and predictive analytics. This will help researchers determine which trial sites perform the best, which patient groups respond best, and how to allocate clinical trial resources most efficiently across the various pharma Clinical Trial Phases.
Likewise, platforms like Clival Database will play a more important role as a way to link public and private trial data, performance metrics of CROs, and regulatory outcomes of both, so innovators spend less time on compliance paradigms and more time on data-driven decisions.
Key Takeaways
- Each Clinical Phase in biopharma development requires distinct data and regulatory considerations.
- CRO clinical trials partnerships increase efficiency and require data systems defensible to regulators.
- A clinical trials database platform, like Clival Database, is essential for contextualizing and validating global trial data.
- Modern clinical trial data solutions are built to reduce manual work and improve decisions.
- Real integration between CROs and sponsors and novel data products and platforms will lead to faster, safer, more compliant clinical trials.