This page is the complete capability catalogue of BioAgile Therapeutics, a CDSCO-registered contract research organisation (CRO) in Bengaluru, India – thirteen distinct services spanning the full product lifecycle — from preclinical work through Phase I–IV trials to post-marketing surveillance.
Every study runs under ICH-GCP within an ISO 9001:2015 certified quality management system, with ethics committee oversight and documentation prepared for Indian regulatory submission. The thirteen services below are grouped by where they sit in the development path, so you can find a single capability quickly. If instead you want the end-to-end engagement in which BioAgile Therapeutics runs a trial as your full-service partner, that model is described in depth on Clinical Research Services.
Clinical Research Services
The end-to-end engagement: protocol design, site selection and management, monitoring, data capture, analysis and reporting, delivered as one accountable programme rather than a set of disconnected vendors. Most sponsors begin here and draw on the specialist services below as the study requires.
Study conduct
Running the study itself, from first-in-human through to comparative bioavailability work.
Clinical Trials (Phase I to Phase IV)
BioAgile Therapeutics conducts interventional clinical trials from first-in-human through post-approval Phase IV. Covers protocol development, ethics committee submission, site identification and monitoring, and CTRI registration under the New Drugs and Clinical Trials Rules 2019.
BA/BE Studies
Bioavailability and bioequivalence studies establishing that a generic formulation performs comparably to its reference product. BioAgile Therapeutics handles subject recruitment, controlled dosing, pharmacokinetic sampling and statistical comparison to the accepted confidence-interval limits.
Preclinical Services
The safety and proof-of-concept package that must exist before a molecule reaches human subjects — in vitro and in vivo evaluation, toxicology and dose-ranging work, documented to support the regulatory application for a first-in-human trial.
Data, statistics and reporting
Turning what the study observed into evidence a regulator will accept.
Clinical Data Management
BioAgile Therapeutics builds and runs the data pipeline behind a study: CRF and database design, validated electronic data capture, query management, medical coding and database lock — with a full audit trail so every value can be traced to source.
Biostatistics
Statistical design and analysis, from sample size determination and randomisation through the statistical analysis plan to final tables, listings and figures. Involving statisticians at protocol stage is what makes a result defensible rather than merely favourable.
Medical Writing
Protocols, investigator brochures, informed consent documents, clinical study reports and regulatory dossiers, written to ICH structure. BioAgile Therapeutics’ writers work from the source data rather than from summaries, so the narrative matches the dataset.
Regulatory, quality and safety
Getting the submission accepted, and keeping the product monitored once it is approved.
Regulatory Support
Classification, submission strategy and dossier compilation for Indian authorities, plus responses to queries once a file is under review. BioAgile Therapeutics maps the applicable pathway before the study is designed, so the evidence generated is the evidence required.
Clinical Quality Assurance
Independent audits of sites, vendors, documentation and processes against ICH-GCP, together with SOP development, CAPA management and inspection readiness. Quality assurance sits outside the study team so its findings carry weight.
Safety Assessment
Adverse event capture, causality assessment, expedited SAE reporting within regulatory timelines, and periodic safety reporting. BioAgile Therapeutics treats safety data as a live obligation throughout the study, not a reconciliation performed at the end.
Post-Marketing Surveillance
Monitoring a product once it is in real-world use, where the population is larger and less controlled than any trial cohort. Covers Phase IV studies, periodic safety update reports, signal detection and real-world evidence generation.
Claim substantiation
Human evidence for consumer-facing products, designed so the resulting claim survives scrutiny.
Efficacy Evaluation
Controlled human studies measuring whether a product does what it claims, with endpoints and instrumentation chosen for the specific claim. Used across nutraceutical, cosmeceutical and FMCG categories where a measurable effect must be demonstrated.
Label Claims Substantiation
Evidence packages supporting what appears on the pack and in advertising. BioAgile Therapeutics works backwards from the exact wording of the intended claim, because a study that proves something adjacent to the claim will not defend it.
Not sure which services your study needs?
Most programmes combine several of the above, and the right combination depends on your product’s regulatory classification and the claim you intend to make. Send us the product profile and the intended market, and our team will map the study design, the applicable pathway and the evidence set required.
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