01Purpose & scope
This Code sets out how Evidilya conducts clinical, scientific and business activity. It builds on the law and on Good Clinical Practice, and it states in plain language the commitments we make to participants, sponsors, colleagues and regulators, everywhere we operate.
Why it matters: a single, written standard means a participant in Milan, Manila or Chicago can expect the same care from us.
- Directors, employees, contractors and consultants; investigators, sites and site staff working under our studies; vendors, laboratories, couriers and technology partners in our supply chain; and everyone who represents Evidilya to a sponsor, a regulator, a participant or the public.
- Every study, every domain and every engagement model, whether delivered full-service, as FSP, under an ECS® licence or as a consultative engagement, in every country where the work is performed.
- Where local law, a sponsor contract or an ethics committee requirement asks for more, we follow the stricter requirement. Where they ask for less, this Code sets the level. Commercial objectives and deadlines are planned around it, never against it.
02Our ethical thesis
Evidilya exists because science succeeds when it reaches people: hospitals, community clinicians, pharmacies and the home, in one ecosystem. Greater reach widens who can take part in research, and it raises what research owes them. We design for both at the same time.
Why it matters: the people most often left out of trials are the ones the evidence tends to serve least well.
- A participant at home is designed the same protection as a participant on a hospital ward: informed choice, medical oversight, privacy, dignity and a way to be heard. Convenience comes on top of that, never instead of it.
- Our studies inform decisions about treatments, devices, foods and care. We treat the credibility of that record as a duty owed to people far beyond the sponsor who funds the work.
- Technology can accelerate, verify and audit. Responsibility stays human: every scientific conclusion and every ethical decision carries the name of a person who stands behind it.
03Participant protection
Protecting the rights, safety and wellbeing of participants is the first commitment of every Recipient, and it comes ahead of every other provision in this Code.
Why it matters: people give their time, their data and sometimes their bodies to research. Consent is how we keep earning that.
- Consent is given before any study-specific procedure, in language the participant understands, with time to ask questions and a named contact to ask them of. Identity-verified eConsent meets the same evidential standard as wet ink: comprehension checked, questions answered by a delegated clinician, withdrawal as simple as enrolment.
- Children, people with cognitive impairment, people in acute distress and anyone dependent on the investigator receive additional safeguards, written into the protocol and approved by the competent ethics committee before enrolment.
- Home visits, at-home sampling, telehealth and pharmacy touchpoints are investigator-supervised and audited exactly like a site visit. Delegation is documented, training is evidenced, and the medical chain of responsibility holds across distance.
- Recruitment is designed to include: geography, language, digital literacy and device ownership are planned for. Where a design relies on technology, an alternative pathway keeps participation open to everyone eligible.
- Reimbursement covers burden, time and expense. It is proportionate, disclosed to the ethics committee, and set at a level that leaves the decision to take part entirely free.
04Scientific integrity
Evidence is valuable because it survives scrutiny. Recipients protect the credibility of the record with the same care whether the finding is commercially welcome or not.
Why it matters: a clinician reading our results will act on them. The record has to be worth acting on.
- Objectives, endpoints and the statistical analysis plan are fixed before database lock. Post-hoc analyses are welcome, labelled as exploratory, and reported as such.
- Negative, null and unexpected results are reported with the same rigour as positive ones. Publication timing and scope follow the science, and the full result reaches the record.
- Authorship follows ICMJE criteria and every contributor is named. Funding, sponsorship and the sponsor's role in design, analysis and reporting are disclosed in every manuscript and presentation. Writing support is acknowledged openly.
- Interventional studies are registered in a public registry before enrolment. Source data, amendments and analytical decisions stay reconstructable through the audit trail for the full retention period.
- Marketing, claim substantiation and scientific communication stay within what the design, the population and the endpoint support. Where a claim needs more evidence, we say what evidence would be needed.
05Independence & conflicts of interest
Interpretation of evidence stays free of commercial pressure, including our own. Interests are a normal part of professional life; declaring and managing them openly is what keeps judgement trustworthy.
Why it matters: a disclosed interest can be managed. That is the whole point of disclosing it.
- Recipients declare financial interests, advisory roles, family relationships, equity holdings and anything else a reasonable observer could see as capable of influencing their judgement. Declarations are made on engagement, on change, and at least annually.
- Declared interests are held in a conflicts register maintained by the ethics owner. Where an interest is material, the individual steps back from the decision, the review is reassigned, and the mitigation is documented.
- Sponsors define the question; the evidence defines the answer. Where a request would shape data interpretation, statistical conclusions or safety assessment, we escalate it promptly and answer in writing.
- Advisory boards, speaking engagements and consultancy are contracted for genuine scientific need, at fair market value, with documented deliverables, and are kept entirely separate from enrolment, prescription or opinion.
06Anti-bribery & fair business
We win work on science, delivery and price, and we expect the same of everyone acting in our name. No advantage is offered, promised, given, requested or accepted to influence a decision, in the public or private sector.
Why it matters: in health research, a bought decision eventually reaches a patient.
- Recipients never offer or accept anything of value intended to improperly influence a public official, healthcare professional, ethics committee member, sponsor employee or anyone else. Facilitation payments are prohibited, including where local practice tolerates them.
- Modest, occasional, transparent and tied to a legitimate professional purpose, always recorded, never cash or cash equivalents, and always paused during a live tender or negotiation.
- Payments to healthcare professionals and organisations are contracted, justified by genuine need, priced at fair market value and disclosed wherever transparency rules apply.
- We compete on merit and respect competitors' confidential information. Price fixing, bid rigging and market allocation have no place in how we grow.
- Counterparties are screened, and transfers of samples and data follow trade-sanction and export-control rules. We keep money laundering and tax evasion out of our business.
- Every transaction is recorded truthfully in the accounting records, in the period it belongs to, with a description that matches what actually happened.
07Data protection, security & AI
Participants share intimate information on the understanding that it will be protected and used only for the purpose they agreed to. We treat that understanding as a promise, and we build our systems to keep it.
Why it matters: trust in data protection is what makes people willing to take part at all.
- Personal data is processed on a documented lawful basis, limited to what the scientific question requires, pseudonymised at the earliest practical point, and retained only as long as the protocol and applicable law require.
- Records are Attributable, Legible, Contemporaneous, Original, Accurate, Complete, Consistent, Enduring and Available. Audit trails and electronic signatures stay active, personal and intact throughout the life of the study.
- Access is role-based and least-privilege, credentials are personal, devices are encrypted. Suspected incidents are reported the moment they are suspected, and reporting early is always the right call.
- Sponsor protocols, commercial terms, unpublished results and colleague data stay confidential during and after the engagement. Raising a safety risk, a data-integrity concern or unlawful conduct is always permitted and always protected.
- AIRA and other AI-assisted tools accelerate literature triage, drafting and signal detection. Models used in evidence-relevant work are documented and auditable, inputs are governed, outputs are verified by a qualified person, and clinical, safety and scientific decisions stay with the named human who signs them.
08Our people
The quality of evidence depends on people who feel safe enough to say what they see. We build the conditions for that deliberately: clear ownership, experienced judgement close to the work, and a genuine welcome for questions.
Why it matters: nearly every serious quality issue was visible to somebody early on.
- Hiring, development, pay and promotion follow capability and contribution. We keep our workplace free of discrimination, harassment, bullying and intimidation, in person and online.
- Employment at Evidilya and along our supply chain is free, fairly paid and freely chosen. Forced labour, child labour and coercive practices are excluded, and working hours and rest follow the higher of applicable law and our own standard.
- Field teams, home-visit nurses and laboratory staff work to documented safety procedures, with training, equipment, and the explicit authority to stop an activity they judge unsafe.
- Concerns raised in good faith are welcomed, investigated and answered. People who report, and people who help an investigation, are protected, whatever the outcome turns out to be.
- Senior by default. Your study is scoped, staffed and overseen by named, experienced specialists, and the people accountable for it stay accountable for it.
09Supply chain & third parties
A study with reach depends on partners: sites, nurses, couriers, laboratories, pharmacies and technology vendors. Our commitments travel with the work, across every contract boundary.
Why it matters: to a participant, everyone who knocks on the door is Evidilya.
- Third parties are qualified on quality, data protection, security, labour standards and integrity before the first activity, proportionate to the risk they carry.
- Contracts carry this Code or an equivalent standard, including anti-bribery, confidentiality and data protection. Sub-contracting is agreed in writing in advance.
- Performance, deviations and CAPA are monitored through the quality system, with support to improve. Where the standard does not hold, the relationship ends.
- Environmental and social criteria form part of supplier selection, in line with our sustainability programme.
11Governance & accountability
Commitments hold when someone owns them, a channel exists to raise concerns, and outcomes follow. This Code has all three, with due process at every step.
Why it matters: people trust a standard they can see being applied.
- The Board of Directors approves this Code. A designated ethics owner maintains it, holds the conflicts register, oversees investigations and reports to the Board at least annually.
- Concerns can be raised with a manager, with the ethics owner, or through the Evidilya whistleblowing channel, which accepts confidential and anonymous reports in line with Directive (EU) 2019/1937 and its national implementations.
- People who report in good faith are protected, whatever the outcome of the investigation, and any retaliation is investigated as a breach in its own right.
- Reports are acknowledged, assessed by people without a conflict in the matter, investigated proportionately and closed with a documented outcome. Confidentiality is maintained as far as the investigation allows.
- Where the Code is breached, proportionate measures follow, up to termination of employment or contract, and referral to the competent authority where conduct is unlawful. Sponsors and regulators are informed where participant safety or data integrity is affected.
- This Code is reviewed at least annually, and whenever regulation, our operating model or an investigation outcome calls for it. The current edition supersedes all previous versions.
