Research Design
From question to defensible study plan
We translate complex questions into robust study designs, selecting appropriate methodologies (quantitative, qualitative, or mixed methods), defining endpoints and outcomes, and setting a clear analysis plan providing practical, high-quality solutions that remain efficient and cost-effective for our partners.
Our Approach
- Problem framing, research questions & hypotheses
- Ethics/IRB preparation and documentation
- Methodology selection (cross sectional, longitudinal, quasi experimental)
- Study design (systematic review & meta analysis reports (PRISMA))
- Protocol development and study governance (SOP driven)
- Sampling strategy & power/sample size calculation
- Instrument development (questionnaires, interview guides) and pilot testing
- Statistical Analysis Plan (SAP) aligned to objectives
First-round IRB/EC approval rate
Protocols approved within 4 weeks (from concept)
Study designs aligned with ICH-GCP & sponsor standards
Protocols needing amendments due to methodological issues
Medical Writing
Publication‑ready,reviewer‑friendly
Our writers and subject‑matter experts produce clear, compliant scientific, regulatory, and medical content, from protocols to manuscripts, documents and conference materials, aligned with leading standards.
What We Do
Manuscripts for Peer-Reviewed Journals
Submission-ready papers that follow the IMRAD structure, with clear narratives, accurate tables/figures, transparent limitations, and rigorous reference management.
Observational Study Reports
Cohort, case-control, and cross-sectional reports aligned to STROBE, with clear methods, handling of confounding and bias, and sensitivity analyses for robustness.
Conference Abstracts, Posters, and Slide Decks
High-impact summaries that translate results into concise abstracts, visually clean posters, and time-boxed presentations tailored to conference guidelines.
Style Compliance
Full adherence to authorship, disclosures, formatting, and citation requirements per ICMJE, AMA Manual of Style, and each journal’s instructions for authors.
Regulatory Documents
Audit-ready authoring and QC of Common Technical Document (CTD) modules, Clinical Study Reports (CSR), Investigator’s Brochures (IB), and Informed Consent Forms (ICF).
Publication Planning, Journal Targeting, and Submission Support
End-to-end support from publication strategy and journal shortlisting to cover letters, submission, and coordinated responses to reviewers through acceptance.
Statistical Analysis
From clean models to clear decisions
Kernel’s biostatisticians and analysts apply fit‑for‑purpose statistical methods to turn data into insights you can defend.
Comprehensive Analytical Approaches
Quantitative credibility indicators
datasets analyzed across therapeutic, public health, and market domains
advanced multivariate and survival models executed annually
advanced multivariate and survival models executed annually
Mean database lock (DBL) to final analysis report
No statistical deviations reported during independent re-analysis or audits
Statistical programming environments mastered (R, Python, SAS, Stata)
Training Courses
Build in‑house capability—fast
We deliver practical, certificate‑ready training for teams at all levels, combining theory with hands‑on exercises and real‑world assignments.