WINNIEDEL ONCOLOGY and Exact Clinical Research Announce Strategic Partnership to Accelerate and Optimize Early-Phase Cancer Trials
The partnership between two oncology powerhouses aims to expedite timelines for study start-up and trial execution, enhance site performance, and enhance patient access to early-phase cancer research.
Houston, TX, and San Diego, CA — July 7, 2025 — In a move poised to transform the early-phase oncology trial landscape, WINNIEDEL ONCOLOGY and Exact Clinical Research have entered into a strategic partnership focused on streamlining trial activation, enhancing site readiness, and expanding access to diverse patient populations.
This collaboration leverages the strengths of two highly specialized organizations: WINNIEDEL ONCOLOGY, the only Contract Research Organization (CRO) exclusively focused on early-phase oncology study start-ups, and Exact Clinical Research, the world’s first Flex CRO with deep operational expertise in the management of trials in oncology and other complex therapeutic areas.
Together, the companies aim to offer biotech and biopharma sponsors a radically more efficient and dependable model for launching and executing Phase I/II oncology studies.
“Winniedel was founded to solve a very real bottleneck in cancer research: inefficient study start-up,” said Dr. Tandy Tipps, Founder and CEO of WINNIEDEL ONCOLOGY. “By partnering with Exact Clinical Research, we’re closing the gap between sponsor intent and site execution. This alignment means trials start faster, reach the right patients sooner, and deliver clean data without unnecessary delays.”
A Shared Mission: Faster Trials, Smarter Execution
The partnership will focus on four core areas:
Accelerated Study Start-Up: Combining WINNIEDEL ONCOLOGY’S speed and startup precision with Exact Clinical’s expertise in clinical strategy and operations, project management, regulatory affairs and quality assurance
Operational Alignment: Seamless communication between CROs to reduce protocol amendments and implementation delays
Diverse Patient Access: Leveraging WINNIEDEL’s global site universe (GOSU) to reach underrepresented populations and meet demographic goals
Trial Quality & Compliance: Joint investment in SOP harmonization, centralized quality oversight, and high-data-integrity
“We’ve worked with many CROs on study start-up, but Winniedel stands out in how they prioritize site activation and trial readiness,” said Shaily Jaini Garg, Principal Consultant and CEO of Exact Clinical Research, a FLEX CRO that provides seamless execution of complex trials. “By joining forces, we’re bringing sponsors a flexible, full-service model that isn’t just fast—it’s collaborative, high-quality, and cost-effective.”
Meeting the Urgency of Oncology Innovation
As biotech and biopharma companies race to bring novel cancer therapies to patients, the need for speed, quality, and executional trust has never been higher. This partnership reflects a broader industry shift toward specialization and focused collaboration, where the right expertise—deployed early—can mean the difference between clinical success and potentially life-saving delays.
Sponsors partnering with WINNIEDEL ONCOLOGY and Exact Clinical can expect:
Trial activation in as little as 90 days in most cases, depending on the therapeutic indication and trial complexity
Reduced site burden through coordinated CRO-site alignment
Pre-qualified sites with oncology-trained personnel and proven enrollment track records
Seamless trial execution by a highly experienced clinical development and operations team
Consistent communication across stakeholders from feasibility to final data (study results)
High caliber trial execution team averaging >20 years experience in clinical development
Flex CRO capabilities, including faster, more experienced study staff, site management and patient recruitment, and vendor management
About WINNIEDEL ONCOLOGY
WINNIEDEL ONCOLOGY is the world's first and only global Study Start-Up (SSU) early-phase oncology Contract Research Organization (CRO). With an extensive global oncology site network and deep relationships with leading Key Opinion Leaders (KOLs), Winniedel Oncology specializes in efficiently aligning early-phase oncology trials to the most suitable sites, significantly reducing timelines and improving trial success rates. Learn more www.winniedeloncology.com
About Exact Clinical Research
Exact Clinical Research is a FLEX CRO offering Sponsors a customizable, cost-effective option for the conduct of their early to mid-stage clinical trials. With locations across the U.S., Exact Clinical delivers rapid, high-quality trial execution by a highly seasoned team of clinical development and operations professionals dedicated to excellence in trial execution and committed to improving outcomes through precision clinical research. Learn more www.exactclinical.com