Sponsor Services
Specialized Solutions
We understand that you may already have a grip on things, so let us step in where you need support. Discover individualized and cost effective solutions for your study.
High-quality data is critical to the success of your study — and that’s where Ethos stands apart. We provide exceptional data management services, including:
Source Data Verification (SDV) Visits and Interim Data Analysis
Electronic Trial Master File (eTMF) creation and maintenance
Investigational Product tracking
Electronic Data Capture (EDC) and Case Report Form (CRF) management
Unbiased Randomization services
Research sites are key to every trial. Ethos equips them for success—while giving sponsors confidence in study progress.
- Monitoring Visits (On-site and remote)
- Site Qualification Visits (SQV)
- Site Initiation Visits (SIV)
- Investigator Training
- Investigational Product Accountability
- IRB approved marketing strategies
Navigating the regulatory landscape is challenging—let our experts guide you through it, so you stay compliant and on track with your study timeline.
- Investigational New Drug (IND) and New Drug Application (NDA)
- Investigational Device Exemption (IDE), 510(k), and PMA submissions
- Medical Device registration
- Trial Management File (TMF)
- Institutional Review Board (IRB) submissions
- FDAAA 801
Customized Project Management services with dedicated experts tailored to the unique needs of each trial, including:
Clinical Research Associates (CRAs) with experience in specific medical indications and device categories
Regulatory experts to manage submissions and ensure compliance
Data Management Associates for accurate, timely data oversight
Biostatisticians with 25+ years of clinical trial experience
Clinical Project Managers to oversee all aspects of the trial and provide sponsors with consistent, real-time progress updates
Full-Service Management
Entrust your entire clinical trial to our experienced team. From protocol development and randomization to TMF management, investigational product handling, regulatory submissions, and beyond. We seamlessly manage every aspect of your study with precision and care.
Site Network
We provide our sponsors access to our premier Site Network. Each site is fully equipped to handle your needs and maintains up to date ICH-GCP certifications and complies with FDA 21 CFR Parts 11, 50, 54, 56, 312, and 812, and more.
Non Competition
Many sponsors accept that their CRO may manage competing trials simultaneously—creating conflicts of interest and stagnant enrollment numbers. At Ethos, we believe your trial deserves undivided focus. We selectively accept trials where we can commit our full resources, ensuring industry-leading success rates and the dedicated attention your research deserves.
Rescue CRO
When trials falter, Ethos steps in. Our specialized rescue team quickly identifies issues, implements targeted solutions, and revitalizes stalled studies. We've successfully rescued numerous trials, saving sponsors valuable time and resources. Let us transform your challenges into success.
All Theraputics
Ethos brings extensive experience across all therapeutics. This breadth of therapeutic knowledge equips our teams to anticipate challenges, implement proven solutions, and navigate the complexities of your specific indication with confidence. Our cross-therapeutic insights ensure your trial benefits from our accumulated expertise—delivering smoother execution and better outcomes.
Clinical research excellence delivered by industry-leading experts
Connect with us and see what sets us apart