Clinical Research Consulting Services

Strategic Clinical Development & Portfolio Advisory

Strategic Clinical Development & Portfolio Advisory services assist biopharma companies in making informed investment decisions by evaluating scientific validity, market potential, and optimizing portfolio strategies through AI-powered insights

  • Help support prepare Clinical Development Plan (CDP) – Phase I - IV
  •  Design out unmet medical need & disease landscape
  •  Indication prioritization & sequencing
  •  Endpoint Strategy (Efficacy, Safety, Surrogates, PROs)
  • Statistical & Adaptive Design Strategy
  •  Safety Management & Pharmacovigilance Strategy
  •  Risk Assessment & Mitigation Strategy
  •  Trial Design & Operational Feasibility Strategy
  •  Site & Country Selection Strategy
  •  Patient Recruitment & Retention Strategy
  •  Diversity & Inclusion Strategy
  •  Medical Affairs & Scientific Communication Plan

Regulatory Affairs & Study Start-Up

Strategic regulatory pathway analysis, health authority engagement, dossier preparation, global submissions, site activation acceleration, and lifecycle change management.

Our Regulatory Affairs and Start-Up services provide comprehensive support throughout the clinical trial lifecycle, from strategic regulatory planning to efficient site activation and post-registration compliance. Leveraging advanced technologies and a global network of experts we offers tailored solutions that streamline regulatory processes, mitigate risks, and accelerate time to market. Our services encompass regulatory strategy development, agency interactions, submission management, and lifecycle maintenance, ensuring that Pharma, biotech and MedTech companies navigate complex regulatory landscapes with confidence and efficiency.

Medical & Scientific Affairs Support

Providing protocol and endpoint consulting, medical monitoring, KOL/SAB engagement, scientific narrative development, publication strategy, and compliant medical communications.

  •  Clinical study document preparation & amendments management
  •  Medical Monitoring & Data Review charters
  •  Endpoint & Outcome Measure Consulting - ClinRO / PRO / ObsRO selection, validation
  • strategy, digital biomarkers
  •  KOL / Scientific Advisory Board (SAB) Planning & Moderation
  •  Publication & Conference Strategy
  •  Publication plan, abstract/manuscript writing, congress slide decks

AI, Advanced Analytics & Decision Intelligence

We empower clients with development and validation of explainable AI/ML models, predictive risk stratification, probabilistic scenario modeling, and secure MLOps frameworks—driving faster, data-driven decisions.


  • Data-Driven Insights

    • Extract meaningful patterns from complex datasets through exploratory data analysis (EDA)

    • Validate findings with rigorous statistical testing to ensure trustworthy results

  • Reliable Decision-Making Under Uncertainty

    • Apply probability models to anticipate risks and outcomes

    • Use classical and Bayesian inference to strengthen predictions and recommendations

  • Optimized AI & Deep Learning Solutions

    • Harness linear algebra techniques (vectors, matrices, tensors) to power scalable, high-performing models

    • Enhance accuracy, efficiency, and interpretability of AI-driven systems

Pharmacovigilance (PV) & Drug Safety

Integrated case processing, global safety reporting, signal detection (including AI-enabled automation), aggregate report authoring, and safety governance for proactive risk mitigation.

  •  Safety Management Plans
  •  Aggregate Report Preparation Support (DSUR, PBRER/PSUR, RMP, SUSAR narratives)
  •  PV Audits & Inspection Readiness (EMA/FDA/WHO expectations)
  • Pharmacovigilance Agreements (PVAs) Drafting & Oversight

Quality, Compliance & GxP Auditing

Risk-based quality frameworks, SOP optimization, vendor oversight, and GCP/GVP auditing—strengthening inspection readiness and continuous improvement.

  • GCP/ GVP / GDP Compliance Audits (site, vendor, lab, TMF)
  • Inspection Readiness (US FDA, EMA, MHRA, PDMA, CDSCO)
  • CAPA plans and implementation

RealWorld Evidence (RWE) & Observational Research

We leverage AI-enhanced curation and analysis of RWD (claims, EMR, registries, wearables) plus systematic literature synthesis—delivering robust insights on effectiveness, safety, burden of illness, and treatment pathways. Our approach ensures a comprehensive evidence base bridging clinical research and real-world practice.

Our RWE and observational research capabilities include:

  • RWE Strategy Roadmaps: Developing structured approaches informed by existing literature and real-world datasets.

  • Registry & Non-Interventional Study Design: Designing robust observational studies aligned with regulatory and scientific standards.

  • Propensity Score & Causal Inference Methodology Support: Applying advanced statistical and AI-driven methods to mitigate bias and strengthen causal interpretation, supported by evidence from published studies.

  • Synthetic Control Arms: Leveraging RWD and literature-based evidence to construct external comparators, enhancing trial efficiency and interpretability.

Digital, Technology & Innovation Advisory

Expert advice on strategic roadmap design for digital trial enablement, platform selection, interoperability, decentralized/hybrid models, and technology value realization (AI/ML use).

  • eClinical Systems Planning: Guidance on EDC, CTMS, eTMF, LIMS, and PV setup.

  • Decentralized Trial Tech: Advice on eConsent, telehealth, eCOA, and wearable/device integration.

  • AI/ML Prioritization: Identifying high-impact AI use cases like enrollment prediction and safety monitoring.

    • Training & Organizational Capability Development

    Evexai's experienced team provides modular, role-based learning (live/virtual) to elevate competencies in GxP, AI literacy, data integrity, pharmacovigilance, and evidence generation—mapped to measurable performance outcomes.

    •  GCP Refresher & RoleBased Curricula
    •  Investigator Meeting Content Development & Facilitation
    •  Protocol & Therapeutic Area Training Modules
    •  Statistical Literacy & Data Interpretation Workshops
    •  SOP & QMS Implementation Training
    • Advisory board meetings

    Scientific & Strategic Advisory Boards

    Evexai design and facilitate evidence-driven advisory boards (KOL, payer, patient) across development and post?launch, generating actionable insights that inform strategy, protocol refinement, and lifecycle optimization.

    Our approach includes strategic planning, expert KOL identification, and content development, ensuring comprehensive coverage of therapeutic areas and seamless execution. Our services are supported by advanced digital capabilities and a network of key opinion leaders (KOLs), enabling efficient and impactful advisory board meetings

    Legal and Ethical guidance for AI enabled solutions

    End-to-end guidance on AI governance, data privacy (GDPR/HIPAA), ethical use, intellectual property, algorithm transparency, bias mitigation, and compliant data lifecycle management.

    Our Services

    • Professional Standards & Ethical Practice

      • Guidance on codes of practice and professional competence

      • Support with ethical decision-making and professional responsibilities

      • Advisory on duties toward clients, employers, and the public

      • Change management and business practice consulting

      • Continuing professional development and lifelong learning programs

    • ICTs & Society

      • Assessment of ICT impact on organizations and society

      • Cybercrime risk assessment, prevention, and response services

      • Digital evidence management and forensic readiness solutions

    • Legal & Regulatory Compliance

      • Advisory on intellectual property rights and protections

      • Support with Data Protection, Freedom of Information, and related compliance

      • Guidance on Computer Misuse Act obligations and cybersecurity laws

      • Health & safety, public liability, and employer liability compliance services

      • Industrial relations and employment law advisory


    Clinical Operations & Study Management

    Full-service study planning, site selection, enrollment optimization, risk-based monitoring (RBM), and vendor coordination to reduce cycle times.

    • Feasibility and predictive country/site selection to start?up package standardization, enrollment forecasting, and mid?course rescue strategies.
    • Our risk?based and centralized monitoring model (RACT, key risk indicators, statistical data review) prioritizes critical data and processes, reducing on?site burden and protocol deviations.
    • Vendor governance, milestone tracking, and real?time KPI dashboards drive proactive issue resolution.
    • Comprehensive TMF oversight, deviation trend analysis, and inspection readiness reviews reinforce compliance.

    Data Management & Biostatistics

    Seamless data acquisition to submission: standards-driven architecture, agile EDC/eSource build, AI?assisted cleaning, CDISC outputs, and regulatory?ready statistical deliverables.

    • Help architect a unified data environment spanning EDC, ePRO, eSource, wearables, labs, imaging, and RWD feeds.
    • Standardized CRF design and rapid EDC/eSource configuration accelerate first?patient?in.
    • AI?assisted anomaly detection, edit check optimization, and reconciliation workflows enhance data integrity while reducing query burden.
    • Biostatistical services cover protocol input, adaptive and Bayesian design support, randomization, SAP development, interim/futility analyses, multiplicity control, and submission response support.
    • Secure, audited programming and traceable metadata ensure consistency, transparency, and regulatory acceptance.