Shodhyantri Engineering Services
Research · Analysis · Editing · Publication Support
Structured support for clinical study protocols, sample size, case record forms, CTRI registration, data analysis and guideline-based reporting for medical and allied scholars.
Tell us about your clinical research support need. We reply within one working day.
Clinical research support at Shodhyantri helps MD, MS, DM, PhD, M.Pharm, nursing and physiotherapy scholars carry a study from idea to report without methodological gaps. We work on protocol structure, study design, sample size, case record forms, ethics committee documents, CTRI registration guidance, statistical analysis and reporting to recognised guidelines such as CONSORT, STROBE and STARD. Support can begin at any stage, even after data collection.
Clinical studies involve patients, so the stakes are higher than in most theses. Design choices affect safety, ethics approval and whether results mean anything. We bring methodological and statistical structure. The clinical question, patient care, consent, data collection and every clinical judgement remain with you and your institution. We support your work; we do not replace your investigators, ethics committee or regulators.
Clinical research studies people to answer questions about diagnosis, treatment, prognosis or prevention. Designs range from randomised controlled trials to cohort, case-control, cross-sectional and diagnostic accuracy studies. In India, research involving human participants follows the ICMR National Ethical Guidelines, requires ethics committee approval, and clinical trials must be registered with the Clinical Trials Registry of India (CTRI) before enrolment begins.
Drug and device trials also fall under the New Drugs and Clinical Trials Rules, 2019, administered by CDSCO. Good reporting follows EQUATOR Network guidelines suited to the design.
We help match the clinical question to RCT, cohort, case-control or cross-sectional design and explain limits of each choice.
Sample size is calculated from your primary outcome, expected effect, power and dropout, with the formula and sources stated.
Case record forms with coded fields and validation rules reduce errors that are costly to fix after enrolment.
We explain where ethics approval, CTRI registration and informed consent fit, so timelines and responsibilities are clear.
A statistical analysis plan written before data collection protects against selective reporting and supports credible results.
Results are structured using the right EQUATOR checklist, which journals often require at submission.
Ten stages, each with a clear output. Nothing moves to the next stage until you have reviewed the last one.
— You review every stage first, then decide —
PICO elements are checked for specificity so the design and outcomes follow logically.
Risks, consent process and vulnerable group protections are reviewed against ICMR guidance.
Assumptions behind effect size and variability are traced to sources and recalculated independently.
Every CRF field links to an objective, and every objective has fields that measure it.
The analysis plan is finalised and dated before outcome data are examined.
The final report is checked item by item against the chosen EQUATOR guideline.
Every stage is shared with notes explaining what was changed and why. You and your supervisor check it, and the next stage starts only after your go-ahead.
| Common problem | How Shodhyantri helps |
|---|---|
| Registering on CTRI after patient enrolment has already started. | We help you plan registration timing so the trial is registered prospectively, as CTRI and most journals expect. |
| Choosing a sample size by convenience, such as fifty per group, without calculation. | We calculate sample size from the primary outcome and prior data, and document every assumption. |
| Changing the primary outcome after looking at results. | Outcomes are fixed in the protocol and analysis plan; any change is reported transparently with reasons. |
| CRFs collecting many fields unrelated to objectives while missing key outcome details. | Each CRF field is mapped to an objective, removing unnecessary items and adding missing outcome measures. |
| Analysing only patients who completed treatment and ignoring dropouts. | We plan intention-to-treat and per-protocol analyses where appropriate, and report losses in a flow diagram. |
| Using the wrong reporting guideline for the study design. | We match design to guideline: CONSORT for trials, STROBE for observational studies, STARD for diagnostic accuracy. |
Deciding tests before seeing data protects credibility and makes the results chapter faster to complete.
Test the case record form on a few patients. Unclear fields show up quickly and are easy to fix early.
Record everyone screened, excluded and enrolled. You will need these numbers for the CONSORT or STROBE flow diagram.
CTRI's registration fields map closely to protocol sections. Writing the protocol with them in mind saves time.
Store patient names in a separate linked key file. Analysis datasets should hold only coded IDs.
State how, when and by whom each outcome is measured. Vague outcomes weaken both analysis and review.
Record and report all adverse events by group. Reviewers and ethics committees look closely at safety data.
Many journals follow ICMJE policy requiring prospective registration. Confirm before you start enrolment.
Your work is handled by people who read your field's literature, not by a single generalist.
A PhD-qualified specialist from your field who checks the research logic, gap and contribution.
Handles statistics, models and qualitative coding, and documents every analytical decision.
Improves structure, flow, clarity and academic tone without changing your meaning.
Builds and validates MATLAB, Python, ANSYS or COMSOL work where your study needs it.
Checks grammar, consistency, numbering, citations and the small errors examiners notice.
Applies your university or journal template, reference style and front matter exactly.
Registration must be completed by the investigator or sponsor through CTRI's portal. We help you prepare the information for each field and review it for consistency with your protocol, so your submission is complete and accurate.
No. Approval comes only from a registered ethics committee. We help you prepare and check documents such as the protocol, consent forms and CRFs against common requirements, so your submission is better organised. The final decision rests with the committee.
Yes. We help refine the question, design, sample size, outcomes and analysis plan within your department's format. The clinical content and the final protocol remain yours and your guide's responsibility. We also align the protocol with your institution's ethics committee format to reduce back-and-forth revisions.
No. Clinical results depend on the intervention and your data, and must be reported honestly. We commit to careful design and properly checked analysis. A well-run study with a null result is valuable and publishable in many journals.
We commonly use SPSS, R and Stata, and can work with data from Excel or REDCap exports. For survival or diagnostic accuracy analysis, R and Stata offer the most complete options. The software and version used are stated in your methods section.
We ask that you share only de-identified data with coded IDs, as most ethics approvals require. Data is used only for your project and not shared or reused. Identifiable records should stay with your institution, and we never ask for patient names, phone numbers or hospital registration numbers.
No. We support design, structure, analysis and reporting checks. Writing the background, discussion and clinical interpretation is your work, and we can review drafts for methodological accuracy. Responsibility for clinical conclusions stays with you and your guide, as institutional rules require.
We provide research guidance, statistical analysis, editing, formatting and training support. All research content remains the scholar's own work, in line with UGC and university academic integrity norms. We do not guarantee publication, acceptance, indexing or academic outcomes: journals decide through peer review and universities award degrees.
Share your topic, draft or data. We will tell you honestly what it needs, and what it does not, before you pay anything.