We have pioneered a new model for clinical development that takes a methodical approach to incorporating epidemiological data and translating that into trial planning, trial conduct, and trial results strategy. This methodology ensures you always have the most highly efficient clinical trial management possible.
Site Management Organization
“The criteria for a good trial are similar in many serious diseases: first and foremost, ask an ‘important’ question and, secondly, answer it ‘reliably’.”
-Salim Yusuf, Rory Collins, Richard Peto
Portfolio Planning & Trial Strategy
Purpose Life Sciences partners with biopharmaceutical companies to swiftly plan and provide curated support to execute clinical trials. We achieve this through three key approaches.
Pioneering novel trial designs
From master protocol designs to adaptive platform trials, we literally wrote the book on innovative trial design. Through these approaches, we help sponsors significantly accelerate trial development.
Employing cutting-edge statistical methodology
Our team works together with you to deploy Bayesian statistics and modeling that reduces time to insight.
Utilizing a data-driven augmented epidemiology discovery platform
Access evidence gap-reducing data with the ability to clean and harmonize multiple data sources that supercharges internal analyses, strategy, and protocols.
Global Trial Conduct
It’s estimated that delays to market caused by clinical trials costs pharmaceutical companies anywhere between $600,000 to $8 million each day[i], with industry estimates reporting that 94% of clinical trials are delayed at least one month.
8,000,000
Est. costs to pharmaceutical companies caused by delay to market
94
Clinical trials delayed at least one month
Our Product Lifecycle Focus is the Answer to This Decades-long Problem
Bespoke clinical trial execution support services range from government-sponsored investigator-initiated trials to regulatory-grade, pivotal industry-sponsored clinical trial programs.
Portfolio planning and strategic development is a comprehensive solution set, tailored to the unique requirements of each sponsor and trial. We efficiently and effectively oversee all aspects of the trial from study design and protocol development to data analysis and reporting. Our approach ensures that the entire process is streamlined, compliant with regulations, and executed with the highest standards of quality.
Purpose Life Sciences offers expertise in:
- Study design and protocol development
- Regulatory and ethical approvals
- Site selection and site management
- Patient recruitment and retention
- Clinical trial operations
- Data management and monitoring
- Statistical analysis and reporting
- Quality assurance and compliance
- Patient safety
- Project management
- Technology integration
Additionally, we leverage our global scientific and clinical investigator relationships to increase trial participant diversity and enable investigation in multiple geographies.
Our end-to-end targeted portfolio planning provides a comprehensive solution for sponsors and investigators. This approach helps ensure the successful planning, execution, and completion of clinical trials with high-quality results.
Trial Results and Post-Approval
At this stage in the development journey, all learnings from each step have fed into the rest. A consistent partner across your journey can capitalize on these synergies while continuing to bring significant support in the following areas:
Regulatory Submissions
Helping you with the thoroughness and accuracy you require for submissions, while continuing to monitor real-time data sources.
- Precision and attention to detail in regulatory submissions are critical, as they can directly influence the approval of life-changing therapies. Purpose Life Sciences consults with sponsors to provide the thoroughness and accuracy required to ensure compliance and maintain and expeditious process. When the time is right, we will also help you leverage augmented epidemiology data to close evidence gaps (e.g., label expansion, efficacy-safety optimization, pharmacovigilance).
Knowledge Transfer
Partnering to find the most effective way to translate your trial findings.
- We offer extensive expertise for sponsors to translate their findings into tangible benefits, including Scientific Publications, Conferences and Symposiums, Patient Advocacy Roundtables, and more. Our team of experts brings an unmatched level of experience in bringing knowledge transfer to life, as evidenced by our library of peer-reviewed publications. In our partnership, we will help you do the same.
[i] Hargreaves, B. Clinical trials and their patients: The rising costs and how to stem the loss. Pharmafile. (Online) Available at: http://www.pharmafile.com/news/511225/clinical-trials-and-their-patients-rising-costs-and-how-stem-loss (Accessed 12.09.17)
You deserve the best trial experience.
Partnering with Purpose Life Sciences puts your study in the best hands, and we’ll be a thorough partner every step of the way. Learn more today.
