Do we need a CRO, a consultancy, or talent, and how do we tell?
Use the shape of the problem. If you need a defined study or workstream executed (monitoring, data management, safety reporting), that is CRO work. If you need expertise to make a decision or pass a milestone (a regulatory strategy, a gap assessment), that is consulting. If you need capable people inside your own process for months, that is talent. Siri operates all three models under one roof precisely so the model can fit the problem, rather than the problem being bent to fit the vendor.
What is inside Siri's CRO service line?
Clinical operations, regulatory affairs, pharmacovigilance, biostatistics, and quality assurance, delivered as full workstreams or as functional support inside your existing structure. Engagements are scoped with named deliverables and oversight expectations, so you always know what you have outsourced and what you have retained.
What does the 48-hour shortlist promise actually mean?
For talent requests, we commit to an interview-ready shortlist within two business days: screened candidates with our assessment notes, not a stack of unfiltered resumes. It is a service standard we designed against the industry's most common complaint (weeks of silence after a job order), and it holds because our life-sciences bench is continuously maintained rather than searched from scratch.
Can Siri implement and validate systems like LIMS and eQMS?
Yes, GxP-compliant system delivery is a core IT service line: selection support, implementation, computerized system validation, and the documentation set that makes the system defensible in an audit. We treat validation as part of delivery, not an add-on, because a lab or quality system that cannot survive an inspection was never really delivered.
How does Siri support EU MDR and IVDR compliance?
Through our regulatory consulting practice and Siri Comply, our QMS-focused offering: gap assessments against MDR/IVDR requirements, technical documentation remediation, and ongoing compliance support for manufacturers selling into Europe. Engagements are led by consultants who work these regulations daily, the pace of European requirements is not something a generalist can track part-time.
What is a functional service provider model, and when does it beat full-service outsourcing?
Under FSP, Siri supplies and manages a function, for example, safety case processing or clinical data review, inside your processes and systems; under full-service, we run the workstream in ours. FSP preserves your SOPs, oversight, and institutional knowledge, and typically suits sponsors with established processes; full-service suits teams that need an outcome without building the machinery. We help clients choose honestly, including recommending the smaller engagement when that is what the problem needs.
How are consulting engagements priced compared with placements?
Consulting and CRO work is priced against scope: fixed-fee for defined deliverables, time-and-materials for evolving work, with assumptions written down before we start. Talent engagements are priced as standard staffing arrangements. Mixed programs get mixed models, stated plainly; surprises in an invoice are a vendor failure, not a client mistake.
How does the global delivery model work in practice?
Client-facing leadership and onsite work run from our US organization; our global delivery hub extends capacity for documentation, data, safety, and IT workstreams. The mix is set per engagement based on data sensitivity, time-zone needs, and your oversight preferences, and it is always disclosed, because a delivery model you cannot see is a risk you cannot manage.
How do you keep consultants audit-ready on client engagements?
Every consultant carries current training records for the GxP context they work in, and engagement leads verify readiness against the client's own SOP and training requirements at onboarding. When your auditors or inspectors ask who touched the work and what qualified them to, the answer should already be in a file, that standard is ours to maintain, not yours to chase.
What can be outsourced in pharmacovigilance, and what should stay in-house?
Case intake and processing, literature screening, aggregate report authoring, and safety database operations outsource well and are core Siri services. Ultimate accountability for safety decisions and signal evaluation judgment should remain with the sponsor, and a PV vendor who offers to take those from you is describing a compliance risk, not a service.
When should a startup first engage regulatory consulting?
Earlier than most do, ideally before the development plan is frozen, because classification, pathway choice, and evidence expectations shape everything downstream. A short strategy engagement at concept stage routinely prevents the expensive rework of discovering a requirement after design decisions have hardened. The most cost-effective consulting we do is the earliest.
What routine knowledge work can Siri's KPO services take off our team?
Structured, recurring workstreams: regulatory intelligence monitoring, document formatting and publishing support, data listings review, literature surveillance, and similar high-volume tasks that consume skilled staff without requiring their judgment. Offloading them is usually the fastest capacity gain a lean team can buy, your specialists go back to the work that actually needs them.
