Clinical Trial Support
Here’s the truth about clinical trials: they’re challenging and often unpredictable, but ultimately they’re critical to delivering better outcomes for everyone.
At Abond we welcome the challenge and are equipped to handle the unexpected. Since 1974, pharmaceutical companies and medical device manufacturers have partnered with us for our expertise, our can-do attitude and our commitment to honest communication.
CLINICAL PROJECT MANAGEMENT
Abond offers Phase I-IV clinical development programs for pharmaceutical and medical device companies. Our project managers understand regulations including Good Clinical Practice, ICH guidelines and local regulations. Along with our CRAs, they leverage therapeutic-specific experience to ensure high-quality data collection as well as proactive and transparent communication.
- Study Management
- Trial Master File
- Vendor Management
Abond has consulted on more than 800 clinical trials and 75 non-clinical trials, collaborating with clients and providing the optimal solutions for any study. In addition, our extensive experience navigating the regulatory process and interacting with the FDA is unrivaled — from preparation for submission to face-to-face meetings and expert testimony.
- FDA Submission Support
- Product Development Programs
- DSMB/DMC Services
Abond’s commitment to quality naturally extends to our site monitoring services. Our Clinical Operations team interacts seamlessly with our sponsors, vendors and the clinical sites to ensure that the programs we execute are conducted efficiently, safely and cost-effectively no matter how complex the study. Our monitoring team ensures that sponsors are always aware of study-related site activities which enables timely decisions for meeting study objectives.
- Site Monitoring
- Investigative Site Selection & Management
- Medical Monitoring
Abond’s extensive data management services include the development of case report forms, design, validation, implementation and management of electronic data capture systems, edit check processing, data review and cleaning, medical history, adverse event and medication coding, and database lock processing and delivery of final subject data.
- EDC Builds, Management & Data Review
- Medical Coding
Because we understand that complete and accurate statistical analyses are fundamental in clinical trials, Abond provides comprehensive and meticulous support. Our biostatisticians work conscientiously to provide statistical study design, data analysis, and interpretation of statistical outcomes. We utilize a collaborative approach to ensure the delivery of timely and reliable trial results.
- Statistical Methods Design
- Sample Size/Power Computations
- Statistical Analysis Plans, Analyses & Reporting
- Design, Development and Production of Integrated Summaries of Safety and Effectiveness (ISS and ISE)
CLINICAL DATA STANDARDS & STATISTICAL PROGRAMMING
With 40+ years of successful regulatory submissions, Abond confidently offers programming services including generation of industry-standard compliant submission datasets and statistical analyses. Regulatory authorities have not required a single correction for computations submitted by Abond for more than a decade, showcasing Abond’s extensive experience, attention to detail and proven quality control process.
- Tables, Figures, Listings
- Patient Profiles
- Customized Data Review Solutions
Abond takes pride in our medical writing expertise. Our writers work side-by-side with our clinical team and biostatisticians to produce robust protocols, clinical study reports (CSRs), investigational annual reports, regulatory briefing documents and scientific journal publications. Abond also has solid experience contributing to, reviewing and co-authoring the sections of eCTD submissions.
- ICH E3 Formatted Study Reports
- Regulatory Submission Materials
- Scientific Publication Support
Abond maintains a modern computing environment tailored to provide a robust and reliable infrastructure capable of seamlessly supporting local and remote operations. The value we place on our role in your trials drives us to take every measure so our employees can be there when you need us. Some key aspects of our system are:
- Secure onsite datacenter
- Redundant connectivity and power
- Offsite replication to regional disaster recovery datacenter
“I hope you have had a chance to see the press release announcing the positive results of our study. I wanted to take a minute to acknowledge all your hard work in getting us to this point! Establishing a professional relationship between a sponsor and a CRO with open communication and a shared sense of purpose can be difficult to achieve, but this relationship is critical to conducting a well-managed study that gives every chance for the drug to demonstrate success. In this case, your oversight of the project and ability to focus your team to meet, and in nearly all cases exceed, our aggressive timeline, is to be commended. Tammy, whenever I asked for information, whether it was about a status report, or a silly question about EDC, your response was prompt and professional. It is so refreshing to be part of a fully functional, well-integrated team. Again, thank you for your teamwork!”
“You guys are amazing. I want to thank you all on behalf of the company, but even more so, personally from me for an incredible job with the study. I signed up for this gig and immediately reached out to Abond for help with our data management for this device study. Right from the beginning you worked through a difficult, unfriendly EDC system and brought some sanity to the process. But what you all did in the last few weeks has been incredible. Just as a point of reference, our last patient evaluation was September. With your help, we had a clean database by early November, and started receiving the statistical output a day later. Not only that, but you provided all the supporting materials, data listings, and the raw dataset for submission ahead of schedule!”
“For the panel meetings, as I mentioned, we supported two sponsors. The stories are similar. Both devices were voted approved with conditions. For one of the meetings we were both present within the seating rows of sponsor support (sponsor staff, KOLs, and us), within the main room for panel discussion. I had a laptop on my lap running analyses. For the other panel, John was in the main room, I was in the “war room” watching the proceedings on a TV, and running analyses. For me, these two still rank as the most intense, high pressure, but most rewarding experiences I have had at Abond.”