September 9, 2026
FOR IMMEDIATE RELEASE
Regulation says what must be true, never how. KA Clinical launches with the plays that fill the gap — sound principles and stronger execution for teams carrying big-pharma obligations without big-pharma infrastructure.
KA Clinical launched today to close a gap biotech and research sites have lived with since small teams started running trials. A twelve-person biotech or a three-person site answers to the same guideline as a company with a thousand people in quality. Until now, its choices were a template that came with no research and no roadmap, or consulting at rates it cannot fund. KA Clinical sells what sits between: the plays, written down by the people who have run them — as free training, ready-to-use kits and, when a document is not enough, hands-on access to specialists who have done the work. They call it Your Pharma Playbook.
“A guideline tells you a trial must be overseen in proportion to its risk. It does not tell you how to operationalize it for next week,” said co-founder Christine Dobek. “Every organization is left with building it from scratch. That is the gap we are filling.”
Free training videos and resources get a team started. Ready-to-use kits and training modules carry the work into the team’s own system — to adopt, adapt and approve as their own — with plain-language guidance, gap assessments, tools, dashboards, templates and worked examples. When the problem is people rather than paper, clients draw on KA Clinical’s growing global network of associates — whose expertise runs from AI governance to how to start a trial in Australia — for engagements from a fixed-scope diagnostic to fractional leadership.
The opening product line addresses ICH E6(R3), the first full rewrite of Good Clinical Practice since 1996 and already in force in multiple jurisdictions.1 R3 rewrites sponsor and investigator responsibilities and adds data governance for the first time. The launch release is a matched set of E6(R3) kits for sponsors and for research sites, each opening with a free gap assessment so a team can see where it stands.
“The E6(R3) upgrade is just the start of a much broader pipeline,” said co-founder Vik Peck. “Next come the plays for CRO oversight, site start-up, inspection readiness and AI governance. Tackling the biggest pain points in pharma one at a time. Same shape every time — the play, written down by someone who has run it, the tools to run it yourself, and the people to call when you cannot.”
Dobek and Peck built the playbook they spent two decades wishing someone would hand them. It is open now at kaclinical.com.
About KA Clinical
KA Clinical is a Canadian pharma consulting and solutions provider. It gives sponsors, CROs and research sites the plays that turn regulatory requirements into daily practice — as free training, ready-to-use kits and hands-on consulting — so that teams carrying the full weight of regulatory obligations without large-pharma infrastructure can be compliant and efficient at once. Sound principles. Stronger execution.
About Christine Dobek, B.Sc., M.Sc.
Christine Dobek has spent seventeen years across research, site, CRO and sponsor roles. She led a CRO through a regulatory inspection that closed with zero critical findings, rescued a 2,500-patient study across 100 sites, led a rare disease trial at 2.5x industry recruitment rate, implemented $4 million in cost efficiencies across program budgets, and led company-wide adoption of ICH E6(R2) and E6(R3). linkedin.com/in/christinedobek
About Vik Peck, MBA, B.Journ./B.Sc., PMP, RAC
Great science fails without excellent execution, and for more than twenty-five years Vik has built the operational architecture that makes it succeed. She has directed programs spanning the full drug development continuum — from discovery through regulatory approval and commercial launch — building program management, alliance and quality functions from scratch, leading global regulatory strategies, and guiding products through phase transitions. Vik managed development portfolios with annual budgets up to US$50 million, navigated Velphoro® through phase 3 and global launch, and helped lead Canada’s first TSX-only biotech IPO in eighteen years. She co-founded KA Clinical to write the playbook drug development never wrote — for teams carrying big-pharma obligations without big-pharma infrastructure. Sound principles. Stronger execution. linkedin.com/in/vikpeck
Media contact
Vik Peck, Co-Founder · vpeck@kaclinical.com · kaclinical.com
1 ICH E6(R3) Principles and Annex 1 in force: EU 23 July 2025 · Switzerland 15 August 2025 · Canada 1 April 2026 · UK 28 April 2026 (legal requirement) · FDA final guidance 9 September 2025. Annex 2: adopted by ICH 3 June 2026; in force in the EU 15 January 2027.