ANNOUNCEMENTS
Partnership with DeepkinetiX
FOR IMMEDIATE RELEASE
DeepkinetiX and TradeCraft Clinical Research Partner to Deliver the Industry’s First System of Record for PK Execution
Joint offering pairs deterministic pharmacokinetic execution with a Regulatory Agency data compliance guarantee, enabling Phase I sponsors to run PK trials with audit-ready rigor from raw data to regulatory artifact.
Philadelphia, May 15, 2026 — TradeCraft Clinical Research, the sponsor-specialization CRO known for its regulatory agency data compliance guarantee, and DeepkinetiX, PK execution infrastructure company behind the KinetixFlow™ platform, today announced a partnership that will give clinical trial sponsors an integrated path for running Phase I PK studies with end-to-end confidence from execution through regulatory submission.
Pharmacokinetics (PK) execution represents only 5–15% of the cost of a Phase I study, but it controls 100% of the regulatory narrative. In complex molecule and oncology programs, fragmented data handoffs between PK analysis and biometrics are not merely operational friction—they are a regulatory risk. A single manual error in the modeling layer can derail an entire submission.
The TradeCraft–DeepkinetiX partnership eliminates that risk by combining deterministic, benchmarked PK execution with a CRO who can boast a 100% submission rate for data packages accepted by the regulatory agency. Together, the companies are delivering the industry’s first System of Record for PK Execution.
Sponsors adopting the joint model gain:
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Deterministic PK Execution—audit-ready PK/NCA benchmarked against industry standards for total numerical equivalence.
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Execution Memory—modeling logic and assumptions that accumulate across programs, eliminating start-from-scratch analyses.
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Audit-Ready Artifacts—automated, structured Word and PDF reports built to inspection standards.
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Submission-Grade Rigor—100% double-programmed, CDISC-compliant SDTM/ADaM datasets and TLFs.
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End-to-End Traceability—full lineage from raw data through to the final regulatory report artifact.
“PK/NCA may represent only a small portion of total study cost, but it sits directly in the path of review, reporting, and regulatory delivery. DeepkinetiX’s execution layer paired with TradeCraft’s total control of the data creates a fully connected workflow from PK execution through downstream study delivery.”
— Mike Willis | TradeCraft Clinical Research, CEO
“Selecting TradeCraft Clinical Research as our partner means that DeepkinetiX can now assure our clients of zero breaks in handoffs, accurate biometrics and traceability within a submission-grade delivery infrastructure needed to carry that work forward into regulatory-ready study execution.”
— Ali Ghayoor, Ph.D. | DeepkinetiX CEO
Sponsors don't buy PK analysis. They buy the confidence that their PK story will hold up months from now, when an FDA reviewer comes back with a question. The DeepkinetiX and TradeCraft Clinical Research partnership is built around that confidence.
About TradeCraft Clinical Research
Founded in 2014 by a team of programming and biostatistician executives, TradeCraft Clinical Research is a sponsor-specialization CRO offering solutions in biostatistics, programming, and proactive project management designed to function as an extension of the sponsor’s team. TradeCraft provides clients a Regulatory Agency Submission Data Compliance Guarantee, giving sponsors Total Control of their data and a clear view of trial strategy and status at every stage—so teams can stay ahead of issues and lead with confidence. Learn more at https://www.tradecraftclinical.com.
About DeepkinetiX
DeepkinetiX builds execution infrastructure for pharmacokinetic and translational modeling workflows. By grounding governed mechanistic models in human-relevant biological evidence, and full decision traceability, DeepkinetiX reduces uncertainty in model-informed decisions. Its KinetixFlow™ platform is built for regulatory scrutiny and reuse across programs. Learn more at https://deepkinetix.com.
Media Contacts
TradeCraft Clinical Research
Kanan Sawyer, Head of Communications and Marketing
kanan.sawyer@tradecraftclinical.com | (610) 935-5754
DeepkinetiX
Eduardo Aponte, Business Development Manager
eaponte@deepkinetix.com | (347) 972-0721
Congratulations...
To our very own Mike Willis (TradeCraft Clinical Research CEO) who was honored for his inclusion in the PharmaVOICE 100. These awards recognize the most inspiring people in the life-sciences industry and include leaders in research and development, marketing, technology, creativity, strategy, and medicine. They acknowledge individuals who positively impact their peers, their colleagues, their companies, their communities, as well as the industry at large through their actions.
CASE STUDIES
CDISC SEND Compliant Data for FDA Submission
The CDISC Standard for the Exchange of NonClinical Data (SEND) is required by the FDA for the submission of nonclinical (animal) data. This case study illustrates how TradeCraft Clinical Research helped a client meet a strict submission deadline by producing CDISC SEND compliant data deliverables.
For teams who are preparing for a major regulatory submission, the CDISC requirements for the data components of the submission can be quite overwhelming. Producing compliant output can be challenging when dealing with legacy studies as well as ongoing trials. Tight timelines often add pressure on teams that are already working at capacity.
Sponsor teams routinely find themselves in difficult situations when they receive clinical data from their contract research organizations (CROs) that is not submission-ready. The data is often received late in the process, leaving little or no time for the team to identify, assess, and correct the issues. Depending on the issues, the output may require minimal rework or extensive reprogramming.
Data Support for Conference Poster
Presenting relevant research data at a conference can help to communicate a sponsor's most recent findings and share the information with broader audiences. However, it can be challenging to present the data in a digestible way that is concise, yet detailed enough for audiences to understand your message.
