Services hero
Services

Specialist FSP Services Across the Early-Phase Clinical Development Lifecycle

Every service Inventio Science provides is delivered by the same senior team, not subcontracted, not staffed with junior resources at delivery, and not managed through layers of account management. You get functional experts who understand the science, own the execution, and are accountable for the outcome.

Clinical Development

Clinical Development
Regulatory Affairs

Regulatory Affairs
Clinical Operations & Biometrics

Clinical Operations & Biometrics
Pharmacovigilance & Drug Safety

Pharmacovigilance & Drug Safety
Outsourced DPO & Privacy

Outsourced DPO & Privacy Advisory
Clinical Development

Clinical Development

Getting a drug candidate from nonclinical package to a well-designed, defensible First-in-Human protocol is a high-stakes process. Protocol decisions made at this stage, starting dose, escalation scheme, biomarker strategy, stopping rules, determine the scientific and regulatory foundation that will inform all subsequent development.

Inventio Science brings senior clinical development expertise directly into your programme: scientists and physicians who have designed and executed FIH, dose-escalation, and Phase II studies across multiple therapeutic areas and regulatory environments.

Services

  • IND/CTA-enabling programme planning
  • Phase I–II protocol development, scientific review, and design optimisation
  • FIH, dose-escalation, proof-of-concept, and healthy-volunteer study design
  • Standard-of-care analysis and competitive-landscape review
  • Medical monitoring, clinical oversight, and real-time safety review
  • Clinical data interpretation and go/no-go decision support
  • Health-authority meeting preparation, FDA Type A/B/C, EMA scientific advice, MHRA interactions
  • GCP quality oversight and clinical quality management per ICH E6(R3)
  • Scientific and strategic support to Clinical Research Scientists and Medical Directors
  • Medical writing: protocols, investigator brochures, clinical study reports, briefing documents
Request a Proposal
Regulatory Affairs

Regulatory Affairs

Regulatory strategy at the IND/CTA stage is a scientific and strategic process that shapes every downstream development decision. A poorly framed IND, a CTA with inadequate nonclinical justification, or a missed opportunity for health-authority alignment can cost months and reset programme momentum.

Our regulatory affairs team brings pragmatic, submission-tested expertise across FDA, EMA, and MHRA. We build regulatory thinking into clinical strategy, so submissions rest on a coherent scientific narrative rather than a last-minute assembly of documents.

Services

  • Early-phase regulatory strategy: IND and CTA planning, jurisdiction analysis, and timeline optimisation
  • IND preparation, review, and submission
  • CTA preparation, national-authority submission, and amendment management (EU CTR, MHRA, and bilateral filings)
  • Scientific advice and health-authority meeting preparation: FDA Pre-IND, Type A/B/C; EMA Protocol Assistance; MHRA Scientific Advice
  • Regulatory intelligence: emerging-guideline monitoring, precedent analysis, and competitive-landscape review
  • CMC regulatory strategy and coordination for Phase I drug substance and drug product packages
  • Clinical trial authorisation amendments, IND annual reports, and safety update filings
  • Medical writing: regulatory briefing books, responses to health-authority queries, summary documents
  • Safety-regulatory alignment: ensuring IND/CTA safety-reporting obligations are met across the programme lifecycle
Request a Proposal
Clinical Operations & Biometrics

Clinical Operations & Biometrics

Phase I execution is unforgiving. Study start-up delays, site-selection errors, and data-management gaps in early-phase programmes affect timelines and generate regulatory questions that can be difficult to answer months later, once the context has faded.

Inventio Science provides senior clinical operations and biometrics support that addresses the specific demands of FIH and Phase I–II trial execution: lean site networks, intensive monitoring requirements, safety data flows, and the need for audit-ready documentation from the first patient screened.

Clinical Operations

  • Clinical project management, study start-up, and full-cycle trial coordination
  • Clinical Research Associate (CRA) support and risk-based site monitoring
  • Clinical scientist oversight, medical monitor support, and protocol deviation review
  • Site feasibility, investigator qualification, and site selection
  • Site contract negotiation and clinical site budget management
  • CRO, central lab, imaging vendor, and IVRS/RTSM oversight
  • Milestone tracking, project planning, and programme risk management
  • ICH E6(R3) GCP compliance oversight and quality risk assessment
  • IRB/IEC and competent-authority submission preparation
  • Trial Master File (TMF/eTMF) setup, ongoing maintenance, QC, and inspection readiness

Biostatistics

  • Statistical analysis plan (SAP) development, biostatistical review, and regulatory alignment
  • Phase I study design: dose-escalation models and adaptive-design input
  • Interim and final statistical analyses for regulatory submissions and data safety monitoring boards
  • Integrated summary tables, listings, and figures for clinical study reports
  • Clinical study report (CSR) statistical sections and regulatory submission packages

Clinical Data Management

  • Clinical data management: database design, eCRF/CRF development, and UAT
  • Data validation, discrepancy management, and database-lock procedures
  • 21 CFR Part 11 and Annex 11-compliant data-quality and audit-trail oversight
Request a Proposal
Pharmacovigilance & Drug Safety

Pharmacovigilance & Drug Safety

In early-phase trials, the safety database is small and every adverse event carries significant weight. Missing a SUSAR deadline, under-reporting a clinically relevant finding, or submitting a DSUR with incomplete safety narratives can trigger regulatory scrutiny and derail a programme.

Inventio Science’s pharmacovigilance team provides safety oversight aligned with FDA IND safety-reporting requirements, EMA/ICH E2A SUSAR reporting obligations, and DSUR preparation standards. We work closely with medical monitors and clinical teams to ensure safety signals are captured, assessed, and reported with the rigour that regulators expect.

Services

  • SAE and SUSAR case receipt, processing, medical review, and causality assessment
  • IND safety reporting to FDA
  • CTA SUSAR reporting to EMA, MHRA, and national competent authorities
  • Development Safety Update Report (DSUR) preparation, quality review, and submission
  • Investigator safety notifications and blind-breaking procedures for SUSARs
  • Scientific-literature surveillance for safety signals relevant to the IND/CTA compound
  • Benefit-risk monitoring and aggregate safety-data review
  • Signal detection, safety-profile tracking, and risk-minimisation strategy support
  • Safety-regulatory alignment for complex multi-jurisdiction IND/CTA programmes
  • Health-authority safety query responses and pharmacovigilance audit support
Request a Proposal
Outsourced DPO & Privacy

Outsourced DPO & Privacy Advisory

Clinical research generates special-category health data at scale, from informed consent to biomarker sampling to electronic health records. Getting privacy compliance wrong in a clinical trial can expose organisations to regulatory enforcement and delay a programme.

Inventio Science provides Outsourced DPO and privacy advisory services designed specifically for clinical research environments. We do not apply generic data-protection frameworks to clinical programmes, we build privacy compliance into trial operations from protocol design, working across EU/EEA, UK, Swiss, US, APAC, and LATAM regulatory requirements.

Services

  • Clinical Data Protection Impact Assessments (DPIAs) and data-flow mapping
  • Records of Processing Activities (RoPA) and Standard Contractual Clause (SCC) review
  • GDPR/UK GDPR privacy integration within TMF, eTMF, and sponsor–CRO data workflows
  • Health-data governance: guidance on special-category data processing under Article 9 GDPR in clinical trials
  • Patient consent and privacy-notice review from a clinical-operations perspective
  • Privacy-by-design review of eCRF, EDC, and clinical data management systems
  • Personal-data breach assessment, regulatory notification support, and escalation procedures
  • Data Subject Access Request (DSAR) management and response procedures
  • Regulatory-authority interaction preparation: ICO, CNIL, BfDI, and other supervisory authorities
  • GDPR awareness training for CRAs, Clinical Project Managers, site staff, and vendor personnel
Request a Proposal

Ready to resource your programme?

Tell us about the functional gap you need to fill, or the full Phase I–II programme you are planning. A senior member of our team will respond within two business days.

Request a ProposalTherapeutic Areas