Clinical data management services

Innowise powers global pharma businesses with smart data management that doesn’t waste time or risk compliance. We’re ISO 27001-certified and trusted by major companies to keep their clinical data clean, consistent, and audit-ready.

100+

healthcare successful projects

40+

data experts

85%

senior and mid-level specialists

Innowise powers global pharma businesses with smart data management that doesn’t waste time or risk compliance. We’re ISO 27001-certified and trusted by major companies to keep their clinical data clean, consistent, and audit-ready.

100+

healthcare successful projects

40+

data experts

85%

senior and mid-level specialists

Services

Projects

Why us

Reviews

Technologies

Process

Clinical data management services we offer

Primary clinical trial data management
Secondary clinical trial data management
Real-world evidence data management

CTMS design & upgrade

As part of clinical study data management services, our team designs CTMS solutions from scratch and upgrades existing systems. We power these solutions with automation and metadata-driven pipelines.

CTMS integration with data sources

To automatically capture clinical trial data, we integrate your CTMS with medical devices, eCRF, and EHR. Our clinical data management support services cover all the bases, so you can be sure no data is lost.

CTMS quality control

A mature clinical trial data management vendor, Innowise builds, configures, and integrates quality control layers based on advanced LLM models. You get full confidence in the data you gather during the clinical trials.

Clinical trial data integration

Our team develops comprehensive integration solutions for secondary clinical data management. These solutions help standardize the data, normalize it, and combine it with other data sources, like real-world evidence.

Secondary clinical trial data analytics

Beyond data aggregation, Innowise builds solid analytical pipelines to conduct secondary data analysis (e.g., subgroup). You get useful insights into the trial results and fact-based trial hypotheses for further study.

Handling & management of RWE

We ingest real-world data from EHRs, registries, lab systems, and devices, and standardize formats. Also, our team reconciles patient IDs, dates, and clinical concepts. You get a trustworthy feed ready for downstream safety or outcomes analysis.

Data collection & cleaning

Innowise captures and curates real‑world data at scale. We deduplicate records, fill gaps, and help preserve longitudinal integrity. Ready for clean, analysis‑ready datasets with traceable changes, validation checks, and review‑ready notes?

RWD database development

Need compliant clinical databases configured fast? We deliver builds tailored to your needs and data model, plus CDM/OMOP/lakehouse architectures with raw/curated/analytics zones, lineage, and access controls.

RWD coding

Innowise’s data experts map medical data across SNOMED CT, ICD‑10‑CM, CPT/HCPCS, LOINC, and RxNorm/ATC. We normalize drugs and conditions and, where relevant, link safety cases so downstream analytics and PV workflows speak a consistent language.

Data reporting

Innowise extracts RWD and delivers clear dashboards: cohorts, longitudinal outcomes, treatment patterns, burden‑of‑illness, and KPI packs for MA, HEOR, and PV teams. You get timely, reproducible insights with audit‑ready outputs.

RWD analysis

When running RWD analyses, we design registries, pragmatic trials, and digital cohorts. Our experts also mine EHR/EMR, claims, registries, dispensations, and device telemetry to answer pressing clinical and commercial questions.

RWE & clinical trial data reconciliation

Bridge the gap between clinical trial data and real-world evidence. We help you integrate the data, normalize, and standardize it at the case level. That’s how Innowise ensures records are ready for further statistical or ML/AI-powered data analysis.

Data validation & quality checks

Completeness, conformance, and plausibility lie at the heart of our proven data‑quality frameworks. With rule catalogs, automated checks, and issue workflows, Innowise delivers transparent metrics and remediation so teams can trust every analytic cut.

Pharmacovigilance signal detection from RWD

Innowise detects PV signals in RWD using disproportionality, sequence symmetry, and temporal scan methods, then supports ICSR E2B(R3) interoperability where needed. We deliver prioritized safety leads with documentation that clinicians can review.

Primary clinical trial data management

CTMS design & upgrade

As part of clinical study data management services, our team designs CTMS solutions from scratch and upgrades existing systems. We power these solutions with automation and metadata-driven pipelines.

CTMS integration with data sources

To automatically capture clinical trial data, we integrate your CTMS with medical devices, eCRF, and EHR. Our clinical data management support services cover all the bases, so you can be sure no data is lost.

CTMS quality control

A mature clinical trial data management vendor, Innowise builds, configures, and integrates quality control layers based on advanced LLM models. You get full confidence in the data you gather during the clinical trials.

Secondary clinical trial data management

Clinical trial data integration

Our team develops comprehensive integration solutions for secondary clinical data management. These solutions help standardize the data, normalize it, and combine it with other data sources, like real-world evidence.

Secondary clinical trial data analytics

Beyond data aggregation, Innowise builds solid analytical pipelines to conduct secondary data analysis (e.g., subgroup). You get useful insights into the trial results and fact-based trial hypotheses for further study.

Real-world evidence data management

Handling & management of RWE

We ingest real-world data from EHRs, registries, lab systems, and devices, and standardize formats. Also, our team reconciles patient IDs, dates, and clinical concepts. You get a trustworthy feed ready for downstream safety or outcomes analysis.

Data collection & cleaning

Innowise captures and curates real‑world data at scale. We deduplicate records, fill gaps, and help preserve longitudinal integrity. Ready for clean, analysis‑ready datasets with traceable changes, validation checks, and review‑ready notes?

RWD database development

Need compliant clinical databases configured fast? We deliver builds tailored to your needs and data model, plus CDM/OMOP/lakehouse architectures with raw/curated/analytics zones, lineage, and access controls.

RWD coding

Innowise’s data experts map medical data across SNOMED CT, ICD‑10‑CM, CPT/HCPCS, LOINC, and RxNorm/ATC. We normalize drugs and conditions and, where relevant, link safety cases so downstream analytics and PV workflows speak a consistent language.

Data reporting

Innowise extracts RWD and delivers clear dashboards: cohorts, longitudinal outcomes, treatment patterns, burden‑of‑illness, and KPI packs for MA, HEOR, and PV teams. You get timely, reproducible insights with audit‑ready outputs.

RWD analysis

When running RWD analyses, we design registries, pragmatic trials, and digital cohorts. Our experts also mine EHR/EMR, claims, registries, dispensations, and device telemetry to answer pressing clinical and commercial questions.

RWE & clinical trial data reconciliation

Bridge the gap between clinical trial data and real-world evidence. We help you integrate the data, normalize, and standardize it at the case level. That’s how Innowise ensures records are ready for further statistical or ML/AI-powered data analysis.

Data validation & quality checks

Completeness, conformance, and plausibility lie at the heart of our proven data‑quality frameworks. With rule catalogs, automated checks, and issue workflows, Innowise delivers transparent metrics and remediation so teams can trust every analytic cut.

Pharmacovigilance signal detection from RWD

Innowise detects PV signals in RWD using disproportionality, sequence symmetry, and temporal scan methods, then supports ICSR E2B(R3) interoperability where needed. We deliver prioritized safety leads with documentation that clinicians can review.

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Check out our portfolio of healthcare and pharma projects

Make data chaos one less thing to worry about

Benefits of clinical data management services for your business

Faster results, fewer delays

After our clinical data services, you get clean data. That means fewer surprises during interim analyses, fewer protocol deviations, and shorter turnaround.

Data you can trust

Innowise’s team builds in multiple layers of validation and reconciliation checks to catch issues early before they turn into rework, delays, or regulatory red flags.

Complete compliance

You won’t have to second-guess whether your CDM is audit-ready. We design our RWE and clinical trial data management solutions to meet HIPAA, GDPR, and FDA (21 CFR Part 11).

Smooth teamwork

With our clinical research data management software, every member of your team can access the necessary information and stay in the loop.

Real-time analytics

You won’t have to wait for end-of-day reports or pull data manually. We build dashboards and exports that give you real-time access to key metrics on the fly.

Ready to grow with you

Running multiple studies? Expanding into new markets? Innowise’s RWE and clinical trial data management software scales alongside your business without risking accuracy.

Why choose Innowise as a clinical data management vendor

Innowise brings 18+ years of healthcare IT experience to every clinical data management project. Being an ISO 27001-certified clinical research data management company, we keep your records clean and secure. You’ll work with sharp data experts and healthcare IT consultants who know the stakes are high and bring results.

Our practical approach to clinical data management services

01/04

Holistic data governance

We set up comprehensive data governance frameworks, looking beyond isolated data points. You get aligned platforms and processes with consistent data at all times.

02/04

Full regulatory compliance

Experienced at compliance with GxP, HIPAA, GDPR, or 21 CFR Part 11, Innowise builds compliance into every workflow, so you don’t face last-minute issues during audits.

03/04

Transparent pricing

You’ll get realistic cost estimates upfront, tied to scope and risk. Without billing surprises halfway through cleaning or reconciliation.

04/04

In-depth clinical data expertise

Our team blends clinical operations knowledge with data management depth, so tech decisions make sense both statistically and in your context.

01

Holistic data governance

02

Full regulatory compliance

03

Transparent pricing

04

In-depth clinical data expertise

Need help with CDM for clinical trials or RWE?

Drop us a line, and we’ll show you how we can streamline your CDM.

What our customers think

Dr. Felix Berthelmann Managing Director Digital Science

“Over the years, Innowise has consistently proven to be a long-term reliable partner. The consistency and quality of the services provided have significantly contributed to the success of our joint initiatives.”

Industry Healthcare, Pharma, Life Sciences
Team size 2 specialists
Duration 44 months
Services Staff augmentation, Data science

Wilman Vergara, MHI Founder & CEO KNOSIS Health, LLC

“Their US Director and Project Manager were very timely with their responses and/or requests. The time difference was a bit of a challenge but that was overcome by the quality of their work. Quick, efficient, and very professional. I would highly recommend.”

Industry Healthcare, Pharma, Life Sciences
Team size 4 specialists
Duration 33+ months
Services AR, Healthcare, Sport, Fitness

Dr. Udo Richter Director n:aip

“Innowise was selected due to its extensive experience of developing complex medical solutions. They managed to quickly and effectively put together a team of IT-specialists. Innowise is characterized by efficient and professional organization of its operation practices.”

Industry Healthcare
Team size 4 specialists
Duration 60+ months
Services Software modernization

Tools we use for clinical data management

InterSystems IRIS for Health
AWS Redshift

Azure Data Factory
Apache Airflow
AWS Glue

REDCap
Medidata Rave

Oracle Clinical
OpenClinica

SAS
R

Tableau
PowerBI

You can’t run trials on unreliable data and expect to get reliable results. Scattered, fragmented data only contributes to the chaos and stops you from making fact-based decisions. In our clinical research data management services, we build systems around this real-world complexity, not some perfect-case scenarios. That’s where the real value lies.

Anastasia Ilkevich

Portfolio Manager in Healthcare and Medical Technologies

Who do we serve

Pharma companies

Biotech companies

Life sciences companies

Contract research organizations

Our clinical data management process

Project kickoff

We align on protocol, timelines, systems, and data flow. You’ll get a comprehensive data management plan that covers logic, data entry process, etc.

Data infrastructure setup

Next, Innowise designs eCRFs and builds a compliant database including all the essentials: field logic, edit checks, validation rules, and integrations.

Data collection

We set up everything you need for hassle-free data collection and, if necessary, handle the migration of existing data into the new system.

Query management

Innowise configures automated triggers to flag inconsistencies or missing info that generate queries and get routed to the right teams.

Reconciliation & QA

When issues occur, our team reconciles data, making sure everything matches. Plus, they routinely check protocol deviations, gaps, and logic issues.

Database lock & support

Once all data is ready, we lock the database and generate submission-ready outputs. But we don’t vanish after that and support you even post-lockdown.

FAQ

What are the three phases of CDM?

Clinical data management usually unfolds in 3 main phases: start-up, conduct, and close-out. At Innowise, we treat each phase as a stepping stone toward audit-ready, analysis-ready data. During start-up, we set the groundwork: creating DMP, setting up the database, and designing eCRF. At the conduct phase, we handle data collection, clean the data, run validation checks, and manage queries. In the end, we tie up all loose ends and lock the database.

How do your clinical data management services ensure data privacy and security during trials?

At Innowise, we follow strict security protocols, including an ISO 27001-certified management system, and we stay fully aligned with GCP and 21 CFR Part 11 standards. What does that mean in practice? All sensitive data is encrypted during transfer, access is role-based and logged for traceability, and we host everything on secure infrastructure. And if GDPR or HIPAA applies, we’ve got that covered when providing RWE and clinical trial data management services.

Can your clinical data management services integrate with our existing systems?

Absolutely, system integration is something we do all the time. If you’re already using an EDC, CTMS, lab software, or any other third-party tools, we can connect those systems to the CDM environment using APIs or middleware.

What support and training do you offer after the implementation of clinical data management services?

You won’t be left on your own once the CDM system’s up and running. After implementation, we make sure your team knows the ins and outs of your CDM setup. That includes full documentation, easy-to-follow training materials, and detailed guides for both end users and admins. And if questions pop up later or if you want to tweak or expand the system, we’re just a message away.

Feel free to book a call and get all the answers you need.

Contact us

Book a call or fill out the form below and we’ll get back to you once we’ve processed your request.

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What happens next?

1

Once we’ve received and processed your request, we’ll get back to you to detail your project needs and sign an NDA to ensure confidentiality.

2

After examining your wants, needs, and expectations, our team will devise a project proposal with the scope of work, team size, time, and cost estimates.

3

We’ll arrange a meeting with you to discuss the offer and nail down the details.

4

Finally, we’ll sign a contract and start working on your project right away.

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