Statistical Analysis Plans (SAPs) Development for Clinical Trials
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5.00 /5.0
User review
I will prepare a comprehensive Statistical Analysis Plans (SAPs) tailored to your clinical trial or medical research project. With over 9 years of experience in biostatistics and regulatory submissions, I ensure your SAPs is compliant with ICH E9/E9(R1), ICH E3, CONSORT, GCP, and CDISC standards.
My SAPs include:
- Clearly defined study objectives and endpoints
- Statistical methodology and analysis strategies (efficacy, safety, subgroup, interim)
- Randomization and blinding considerations
- Sample size justification and power analysis
- Handling of missing data, estimands, and sensitivity analyses
- Pre-specified tables, figures, and listings (TFLs) for submission
Whether for FDA, EMA, BLA, or MAA submissions, I deliver publication- and submission-ready SAPs that stand up to peer review and regulatory scrutiny.
Fequently asked questions
1. How does it work?
Send me your study details or protocol. I will review, suggest the best package, and deliver a draft SAP for your feedback before finalising.
2. Is my data confidential?
Yes. All documents are kept secure and never shared. NDAs can be signed if required.
3. Which studies do you cover?
I prepare SAPs for RCTs, cohort, prospective, observational, and healthcare studies.
4. What guidelines do you follow?
SAPs are prepared in line with ICH E9/E9(R1), ICH E3, CONSORT, GCP, and CDISC standards.
5. Which software do you use?
Mainly SAS and R, with experience in Stata, SPSS, PASS, and East for specific tasks.
6. Can you also do the analysis?
Yes. I can carry out the analysis, generate TFLs, and support CSR preparation after the SAP.
7. How long does it take?
Basic SAP: ~1 week. Full SAP: ~2 weeks. Regulatory SAP: ~3 weeks.
8. Do you include estimands in line with ICH E9(R1)?
Yes. I specify treatment, population, variable, and summary measure estimands, with pre-planned sensitivity analyses.
9. How do you handle missing data?
I outline strategies such as multiple imputation, mixed models, and sensitivity checks depending on study design and regulatory needs.
10. Can you define analysis populations (ITT, PP, Safety)?
Yes. Each SAP clearly defines analysis sets, inclusion/exclusion rules, and handling of protocol deviations.
11. Will the SAP include TFL shells?
Yes. Table, Figure, and Listing (TFL) shells are included for regulatory submissions and CSRs.
5.0
(4 weeks ago)Very professional work
Eren understood our clinical trial protocol quickly and produced a high-quality SAP that passed internal and regulatory review without issues