Clinovate is Spirant's full-service clinical research division. We design and run clinical trials, generate real-world evidence, build health economic and value arguments, and write the regulatory and scientific documents that carry a molecule from protocol to payer, for pharmaceutical, biotech and medical device companies working across chronic and complex diseases.
Most research partners stop at the clinical study report. Clinovate is built to keep going: from study design and site management through evidence synthesis, value storytelling and safety surveillance, so the data you invest in actually reaches the clinicians, regulators and payers who need to act on it.
Clinovate supports international clinical trials, real-world evidence studies and health economic research. Because we sit inside a full-service healthcare agency, the same organisation that writes your protocol can also prepare your congress abstracts, plain language summaries and Global Value Dossier. That continuity removes the slow, error-prone hand-offs between vendors and keeps one consistent scientific narrative across every deliverable.
We work for pharmaceutical, medical device and biotech sponsors, from first protocol concept through post-marketing commitments. Teams are scoped to the study, governed by written quality procedures, and aligned to ICH-GCP from the first day of planning.
Study design and protocols, study documents and reports, medical monitoring inputs.
Prospective and retrospective studies, registries, surveys and patient outcomes.
HEOR, evidence synthesis, systematic literature reviews and value and access evidence.
Manuscripts, congress abstracts and posters, and plain language summaries.
Engage Clinovate for a single deliverable or for the full development and post-approval journey. Each practice is self-contained, yet built to share data, documents and people with the others.
Planning and running studies that recruit on time and stand up to inspection, with risk-based oversight and real-time monitoring built in from start-up.
Regulatory strategy, dossier preparation and submission support for national and international authorities, including FDA, EMA and MHRA pathways.
Clinical, regulatory and scientific writing alongside the medical affairs activities that turn evidence into informed clinical practice.
Observational studies, registries, evidence synthesis and economic arguments that show how a therapy performs and what it is worth outside the trial setting.
Clean, standards-compliant study data, from database design and EDC build to validation and CDISC-ready datasets.
Statistical thinking from protocol design onwards: sample size, programming, analysis, adaptive designs and real-world evidence analytics.
Case processing, signal detection and periodic reporting, supported by analytics that help surface safety patterns earlier.
Programmes that help patients start, afford, understand and stay on therapy, designed with privacy and pharmacovigilance obligations in mind.
Recruitment delays and data queries are where trial budgets disappear. Our operations model front-loads feasibility and risk planning so that sites, patients and data stay on track through last patient out.
Protocol feasibility, country and site assessment, patient population and competing-study review.
Investigator identification, qualification visits and site agreements.
Ethics committee submissions, essential documents, training and site initiation.
Recruitment and retention plans tailored to each site and indication.
Monitoring, query management, issue escalation and real-time study dashboards.
Database lock support, site close-out, archiving and inputs to the CSR.
PLANWe test the protocol against real site capacity and patient availability before a single contract is signed, so timelines are built on evidence rather than optimism.
PROTECTEvery study runs under ICH-GCP, applicable national regulations and written SOPs, with documented training and a living trial master file.
PERFORMSponsors see enrolment, data entry, queries and site performance as it happens, so issues are addressed in days rather than discovered at interim review.
A submission is only as strong as the strategy behind it. We help sponsors decide which evidence they need, which pathway fits, and how to sequence filings across markets, then we prepare dossiers that reviewers can navigate with confidence.
Our regulatory team works across national requirements and the international pathways of the US FDA, the European Medicines Agency and the UK MHRA. We support new applications, variations, renewals and the lifecycle work that keeps a product compliant long after approval, with compliance audits that identify gaps before an authority does.
Pathway assessment, gap analysis, authority meeting preparation and multi-market filing plans.
CTD-structured dossiers, including Module 2 summaries and supporting documentation.
IND, NDA and BLA support, responses to authority queries and submission tracking.
Independent reviews of documents, processes and systems against applicable standards.
| Stage | What we deliver | Why it matters |
|---|---|---|
| Development | Regulatory strategy, pre-submission meeting packages, briefing documents | Aligns evidence generation with what authorities will expect to see |
| Submission | IND / NDA / BLA support, CTD dossiers, Module 2 summaries | Clear, consistent dossiers reduce avoidable review questions |
| Review | Query responses, labelling inputs, document updates | Fast, well-referenced responses keep review clocks moving |
| Post-approval | Variations, renewals, lifecycle management, safety reporting links | Keeps the licence current as data, sites and markets evolve |
Our medical writers produce every major document in the development lifecycle. Because one team owns the chain, terminology, data presentation and key messages stay consistent from the first protocol draft to the final value dossier.
Objectives, endpoints, design rationale and statistical sections written with operations and biostatistics.
Participant-friendly informed consent and investigator's brochures kept current with emerging data.
ICH E3-structured CSRs with clear narrative, tables and appendices.
Clinical overviews, summaries and authority briefing documents.
Periodic safety reports and post-marketing documentation.
Evidence translated into value arguments for payers and HTA bodies.
Every document follows the guideline that governs it, with a documented review trail covering scientific accuracy, data verification against source, and editorial quality. Publications follow authorship and disclosure norms, and promotional derivatives are routed through your MLR review.
Original research, reviews and secondary analyses prepared for peer-reviewed journals.
Congress-ready abstracts, posters and oral presentation slides.
Trial results explained clearly for patients, carers and the public.
Monographs, MSL tools and medical information responses.
Randomised trials prove efficacy under controlled conditions. Real-world evidence shows effectiveness, safety and treatment outcomes in the patients doctors actually see, with their comorbidities, co-medications and adherence challenges.
We design prospective and retrospective studies, establish disease registries and run physician and patient surveys. Each study starts with a precise research question and a fit-for-purpose data source, followed by a protocol and statistical analysis plan written to the same standard as an interventional trial, with ethics approvals and data protection safeguards in place.
Observational cohorts that follow patients forward in routine care.
Analyses of existing records to answer questions quickly.
Long-term, structured data collection in a disease or therapy.
Practice-pattern, perception and patient-reported outcome surveys.
Data sources are selected for each research question and accessed only under appropriate approvals and data protection safeguards.
Payers, hospital formularies and health technology assessment bodies ask a different question from regulators: is this therapy worth it? Our HEOR team builds the evidence that answers that question rigorously.
Protocol-driven searches, screening and data extraction to established reporting standards.
Combining published and study data to compare therapies and quantify relative benefit.
Burden of disease, quality of life and resource use studies that frame the unmet need.
Economic arguments and access materials tailored to payers and decision-makers.
Evidence earns approval. Value earns access.
HEOR is most powerful when it is planned alongside the clinical programme, not bolted on afterwards. We help teams identify the outcomes payers will care about early, so that trials and real-world studies capture the right endpoints the first time.
A Global Value Dossier brings clinical, economic and humanistic evidence together into a single, referenced value story that regional and local teams can adapt with confidence, instead of each affiliate building its own argument from scratch.
Trial data, real-world evidence, literature reviews and economic analyses gathered and graded.
The core argument: unmet need, clinical benefit, economic value and patient impact.
A structured, fully referenced dossier with a highlighted reference binder.
Market-specific data, pricing context and HTA requirements layered in.
Objection handlers, payer slide decks and training for market access teams.
A clear case for budget impact and value for money.
Transparent methods and evidence that can be appraised.
Consistent clinical messages aligned to the approved label.
A ready foundation for market-specific dossiers and launches.
New data, new indications and new competitor launches change the value story. We maintain GVDs through the product lifecycle, with version control, a reference library that tracks every claim to its source, and update cycles timed to major data readouts.
Regulators, reviewers and payers will question your numbers. Our data managers and biostatisticians work together from protocol design so that every dataset, table and analysis can be traced, reproduced and explained.
We design databases around the protocol, build and validate EDC systems, write edit checks that catch errors at entry, and manage queries through to database lock. Risk-based data management focuses review effort on the data points that matter most to safety and the primary endpoints.
eCRF design, data dictionaries and edit specifications.
System build, user acceptance testing and documented validation.
Systematic discrepancy review and site query resolution.
Targeted review driven by critical data and risk indicators.
Good statistics begins before the first patient is enrolled. Our biostatisticians contribute to protocol design and sample size, write the statistical analysis plan, programme the analyses and help interpret the results, including adaptive designs and real-world evidence analytics where conventional approaches fall short.
Endpoints, randomisation and analysis populations.
Justified calculations and sensitivity scenarios.
Validated datasets, tables, listings and figures.
Interim designs and methods for observational data.
| Area | Approach |
|---|---|
| Data standards | CDISC-aligned datasets to support regulatory submission and reuse |
| Validation | Documented system validation and independent programming checks |
| Traceability | Audit trails from source data to final tables and figures |
| Privacy | Pseudonymisation, access control and applicable data protection requirements |
| Governance | Written SOPs, trained personnel and ICH-GCP-aligned quality oversight |
Patient safety obligations continue for as long as a product is on the market. We support sponsors with case processing, signal management and periodic reporting, combining trained safety professionals with analytics that help surface emerging patterns earlier.
Collection and triage of adverse events from trials, programmes, literature and spontaneous reports.
Intake, coding, medical review, narrative writing and regulatory submission within required timelines.
Systematic review of aggregate data to detect, validate and assess potential safety signals.
PSURs and other periodic safety documents prepared to applicable formats.
Risk management plans and minimisation measures, with effectiveness checks.
Analytics that support reviewers in spotting trends across large case volumes, always with human medical judgement.
The best medicine fails if patients cannot get it, do not understand it or stop taking it. Our patient support programmes address each of those barriers, designed with consent, privacy and adverse event reporting obligations built in.
Guidance on access and affordability pathways.
Disease and therapy materials written in plain language.
Onboarding, dose reminders and helpline support.
Tracking persistence and intervening early when patients drift.
Every sponsor organises research differently. Clinovate adapts the engagement to your team, while the quality system, the review discipline and the regulatory standards stay exactly the same.
Our writers, statisticians or study managers extend your in-house medical, clinical or regulatory function, working inside your templates, systems and governance.
For sponsors without a dedicated function, we take ownership of the programme end to end, from evidence strategy and protocol to reporting, publications and value dossiers.
Defined deliverables with a clear scope, timeline and review plan, ideal for a single study report, literature review, registry analysis or dossier update.
| Quality principle | How it shows up in your project |
|---|---|
| Documented procedures | Written SOPs for writing, data handling, monitoring and safety activities, with training records for every team member |
| Scientific accuracy | Independent quality control of data against source, references checked claim by claim |
| Regulatory alignment | Deliverables structured to ICH, CTD and journal guidelines from the first draft |
| Compliance review | Promotional derivatives routed through sponsor MLR review and aligned with UCPMP where applicable |
| Confidentiality | Controlled access to sponsor data, confidentiality agreements and secure document exchange |
Science-led. Compliance-minded. Built for the full brand lifecycle.
Clinovate connects to the rest of Spirant. Evidence generated here flows into certified medical education through Medigene, brand and scientific communication through Think Nest, and HCP content delivery through MedShort, under one quality system and one point of contact.
If your question is not answered here, our team will be glad to walk you through how Clinovate would approach your study or dossier.
We support pharmaceutical, biotech and medical device companies, from teams running a single investigator-supported study to sponsors managing multi-country development and post-approval programmes.
Yes. Many engagements begin with one deliverable, such as a protocol, a CSR, a systematic literature review or a value dossier. Each practice can work independently or alongside your in-house team and other vendors.
Documents are written to the guideline that governs them, including ICH-GCP, ICH E3 for study reports, CTD for dossiers, CONSORT for trial reporting, and ICMJE and GPP for publications, alongside any sponsor-specific templates.
We provide regulatory consulting, dossier preparation and submission support for national authorities and international pathways, including FDA, EMA and MHRA, covering IND, NDA and BLA support and lifecycle management.
A clinical trial tests a therapy under controlled conditions in a selected population. Real-world evidence studies how it performs in routine practice, using data such as electronic health records, claims, registries, wearables and patient-reported outcomes. The two are complementary.
A GVD brings together the disease burden, unmet need, clinical evidence, economic value and patient impact of a therapy into a single referenced value story, supported by a highlighted reference binder. Regional and local teams then adapt it for their markets and payers.
Studies operate under ethics approvals, informed consent and applicable data protection requirements. We use pseudonymisation, role-based access and audit trails, and only access real-world data sources under appropriate agreements.
Analytics help reviewers spot trends across large volumes of case data, but causality assessment, signal evaluation and regulatory decisions always remain with qualified safety professionals.
Programme staff are trained to recognise and report adverse events, and every programme includes a documented pathway that routes safety information to the sponsor's pharmacovigilance system within agreed timelines.
Yes. With your approval, study findings, publications and value messages can be adapted into certified education through Medigene, scientific brand communication through Think Nest and HCP content libraries through MedShort, always within the approved label and your MLR process.
Clinovate operates from Spirant's headquarters in Noida, India, supported by the group's service locations in India and its presence in Dubai UAE, Singapore and Gloucester UK.
Tell us where your programme stands and what decision you need the evidence to support. We will come back with a scoped, compliant plan.
Clinovate services are delivered in accordance with applicable regulations, ICH-GCP and sponsor-approved procedures. Promotional materials derived from scientific content are subject to the sponsor's medical, legal and regulatory review. Figures shown reflect the Spirant group.