How it works # The living blueprint of your clinical trial. Cori reads your protocols, RFPs and past trials into one versioned record, the Knowledge Hub, enriched with trusted external sources. Feasibility, design, risks, the bid and budget, submissions and review all work from it, before the trial starts and while it runs, and each saves its decision back. [Book a demo](https://www.cori-clinical.com/contact) [See the modules](https://www.cori-clinical.com/platform#modules) - ISO/IEC 27001 certified - GxP aligned - Hosted in your region ## Knowledge Hub Mapped to CDISC USDM v4.0. - Feasibility and strategy Scenario chosen - Design and SoA Design chosen - Trial risks Owners set - Bid and budget Budget agreed - Regulatory package Drafting - Compliance review Next Each module reads what the others decided, in any order, and saves its own decision back. The modules ## Every module starts from what the others already decided. - [Feasibility and strategy](https://www.cori-clinical.com/platform#feasibility) - [Design and SoA](https://www.cori-clinical.com/platform#design) - [Trial risks](https://www.cori-clinical.com/platform#risks) - [Bid and budget](https://www.cori-clinical.com/platform#bid) - [Regulatory package](https://www.cori-clinical.com/platform#package) - [Compliance review](https://www.cori-clinical.com/platform#review) - [Amendments](https://www.cori-clinical.com/platform#amendments) - [Decision records](https://www.cori-clinical.com/platform#decisions) Feasibility and strategy Where and how ### Build the strategy on what comparable trials did. The challenge Country and site choices often rest on a few people's memory of past trials, and the evidence behind a strategy is hard to show to the sponsor or the rest of the team. Cori drafts the ways the trial could run and scores each against comparable trials, yours and those in curated registries. Sample study What it changes - #### Scenario planning Several ways the trial could run, side by side. - #### Your ideas, tested the same way Describe a change in plain words. The original stays, and your variant is scored against the same evidence. - #### A strategy you can defend Each score shows the trials behind it, and says so when there are none. Design and SoA What to run ### Design the trial you can deliver. The challenge Designs are usually judged on the science first. Their cost, duration and burden on sites and participants show up later, when they are expensive to change. Compare design options on duration, cost and site burden, not only on endpoints. Sample study What it changes - #### Fewer surprises later Recruitment, startup time and outcomes from registries and your own delivered trials. - #### Cost and burden, seen while it is still a choice Duration, visits per participant, cost and endpoint risk, side by side. - #### One schedule, everything follows Edit the visit grid in place. The budget and the documents follow it. Trial risks What could go wrong ### See the risks before you commit. The challenge Risk registers are often filled in from experience and revisited rarely, so a risk is found when it lands rather than while there is time to plan around it. Each risk is scored on how often it appeared in comparable trials, when it landed and what it cost. Sample study What it changes - #### Risks found while there is time to act Each risk comes with how it played out on comparable trials, yours or public ones. - #### Scores you can trace Likelihood and impact come from comparable trials and regulatory findings. - #### Flagged again when things change Each risk has an owner and a plan. When the design or the regulations change, Cori flags the risks that change with them. Bid and budget What it costs ### A budget that moves when the design does. The challenge Bids are priced under time pressure from spreadsheets and memory, and each line is hard to defend when the sponsor pushes back. The site budget is projected from the Schedule of Assessments. CROs price each bid line on trials they delivered, with public benchmarks where their own data is thin. Sample study What it changes - #### Bids you can defend Each bid price shows the comparable trials it came from. - #### Per site and per country Site and country budgets are broken out from the same schedule. - #### Every negotiation round kept Each round is a snapshot, so you can show what changed and why. FSP bids Dedicated roles ### CROs price dedicated roles on their own grades. When a CRO places dedicated staff with a sponsor, Cori reads the sponsor's job descriptions and maps each role to the CRO's grades, with its reasoning shown. The rate card by role and country is built from its grade cost bands and checked against the rates it won at, restated to today's terms, with lost bids alongside. Sample study What it changes - #### Graded on scope A Site Manager role with Senior CRA scope is graded and priced for that scope, so the rate matches the work asked for. - #### Contract terms in the margin The escalator, USD rates with no FX clause, and vacancy and backfill cost, each shown in contribution margin before the bid goes out. - #### Past bids, with the debrief Each bill rate sits beside the FSP rates won and lost before, with the sponsor's debrief attached. Regulatory package Protocol to country packs ### The package for every country, from one blueprint. The challenge Every country needs its own documents and translations, all consistent with the protocol. Keeping them aligned by hand is slow, and gaps are often found late. Cori drafts the protocol on your templates, then the consent form, submission documents and each country's pack, and names the gaps while there is time to close them. What it changes - #### Protocol first, everything consistent Drafted from the design, the schedule and the decisions already made, with the consent form and submission documents kept consistent with it. - #### Every country covered The local documents each country needs, including Part II for each EU member state. - #### Translations that keep their format Each document translated for its country, with structure and formatting kept. Compliance review Against the rules ### Reviewed against your SOPs and the rules that apply. The challenge Reviewers check each document by hand against regulations, guidance and SOPs, and findings live in email threads and tracked changes. Each draft is checked against ICH GCP, the regulations of each trial country, your SOPs and the rest of the record. Findings are pinned to their passage, and nothing moves on until a reviewer signs it off. What it changes - #### Your standards, every time Every draft is checked against your own standards. - #### The rules that apply, checked ICH GCP, the EU Clinical Trials Regulation, FDA regulations and national law in each trial country. - #### Documents that agree with each other Flags where a document disagrees with the design, the schedule or another document. Built into every module ## A change reaches every module, and the reasoning stays. Amendments When it changes ### Change once. See everything it touches. The challenge One amendment can touch many documents, country packs, budget lines and dates. Finding them all by hand is slow, and anything missed becomes rework or unbillable work. Once an amendment is approved, Cori redrafts the affected sections and, for CROs, the change order. What it changes - #### Impact before commitment Every affected document, cost and date, listed before anyone agrees to the change. - #### Redrafted for your review Your team reviews redrafted sections instead of editing each document and country pack by hand. - #### Change orders with evidence Each one carries the design change behind it and comparable changes from your history. Decision records The reasoning ### Each decision is saved with its evidence and the person who approved it. The challenge The reasoning behind a decision usually lives in meeting notes and inboxes, and leaves with the people who made it. Every step records the question, the options considered, the evidence and the approver. What it changes - #### Recorded as you work Captured where the decision is made, with no separate log to keep. - #### Read by every step Budget, documents and review start from the decisions already made. - #### Your organisation's memory The next trial can look up what was decided before and how it turned out. The record itself ## Every value shows where it came from. Each field shows whether a person, a file or Cori supplied it, and earlier versions stay on record. Every field shows the document and section its value came from. The visit grid, edited in place, with a window flagged where it disagrees with the protocol. Where Cori sits ## Works alongside the systems you already run. Your CTMS, RIM, eTMF and document systems stay the systems of record. Cori keeps the blueprint beside them, with every value traced to its source. Your systems of record - CTMS - RIM - eTMF - Document systems Cori, alongside them The living blueprint of the trial, with its drafts and decisions. They stay as they are. Nothing to replace. Your data, your decisions ## Your trial runs in its own environment. ### Your own environment Each customer has its own deployment, hosted in its region. Your data is never used to train models. ### Cori drafts, a person decides Nothing is applied until someone approves it. When Cori cannot find a source, it asks. ### Every value traces back Each value shows who supplied it: a person, a file or Cori. Earlier versions too. ### Certified, and every action logged ISO/IEC 27001 certified, with EU, US and UK data residency. An altered log entry shows. [Security and compliance](https://www.cori-clinical.com/security) ## See what it changes for your team. [I'm a sponsor Leaner team, faster to first participant in](https://www.cori-clinical.com/sponsors) [I'm a CRO Price on precedent, defend every change order](https://www.cori-clinical.com/cros) ## See it on a trial of your own. Book a demo with us. [Book a demo](https://www.cori-clinical.com/contact)