Formedix
Formedix provides clinical trial automation software that standardizes, validates, and packages study data for CDISC-compliant regulatory submissions. It serves pharmaceutical companies, CROs, and biotechs, and has been a Certara subsidiary since October 2023.
- Company typePrivate
- Founded2000
- HeadquartersBurlington, United States
- Headcount11–50
- GTM typeB2B
- OfferingSoftware
What Formedix does
Formedix is a clinical trial software company that automates the standardization, validation, and submission of clinical study data to regulatory authorities. Its core technology centers on enforcing CDISC data standards (SDTM, ADaM, SEND, define.xml) for submissions to the FDA, PMDA, and NMPA, and it packages this capability into Pinnacle 21 Enterprise, a modular platform comprising a Clinical Metadata Repository (CMDR), CRF design and EDC visualization tools, automated data validation, define.xml generation, Study Data Reviewer's Guide automation, SDTM specification management, and external vendor data exchange. A free Pinnacle 21 Community edition offers basic validation utilities (Validator, Define.xml Generator, Data Converter, ClinicalTrials.gov Miner) as a top-of-funnel channel for enterprise sales. Native integrations with Medidata Rave and Veeva Vault embed the software into the dominant EDC environments used by clinical operations teams.
Formedix primarily serves pharmaceutical companies running clinical trials, with secondary reach into contract research organizations (CROs) and biotechnology companies that need consistent, submission-ready datasets. The company's value proposition is the reduction of manual rework and rejection risk in regulatory submissions, delivered through pre-built, standards-compliant metadata and validation rules accumulated over more than two decades.
Formedix was a privately held LLC until it was acquired by US-based Certara Inc. in October 2023, after which its technology and products were folded into Certara's software portfolio. Pricing is not publicly disclosed, and the company is no longer reported as an independent operating entity; under Certara, the offering is delivered alongside complementary products such as Phoenix, GlobalSubmit, Simcyp, and SEND Explorer, and is covered by Certara's ISO 27001-certified Information Security Management System.
Formedix firmographics
Firmographics- Name
- Formedix
- Legal name
- Formedix LLC
- Website
- https://formedix.com
- Company type
- Private
- Founded year
- 2000
- Operating status
- Acquired
- Headcount range
- 11–50 employees
- Short description
- Formedix provides clinical trial automation software that standardizes, validates, and packages study data for CDISC-compliant regulatory submissions. It serves pharmaceutical companies, CROs, and biotechs, and has been a Certara subsidiary since October 2023.
- Ownership category
- akta.pro rank
Formedix industry classification
Industry- Product category
- Clinical Trial Data Standardization Software
- NAICS
- Computer Systems Design Services (541512)
- SIC
- Services-Prepackaged Software (7372)
- akta.pro primary industry
- Regulatory Strategy & Global Submissions (IND/CTA/NDA/BLA/MAA) (HLAGAKAA)
- akta.pro secondary industry
- Site Data Management Support (EDC/Source/SDV Readiness) (HLAGACAL)
Keywords
Where Formedix is headquartered
LocationHeadquarters
- HQ city
- Burlington
- HQ country
- United States
- HQ region
- North America
Markets served
Formedix business model
Business model- GTM type
- B2B
- Offering type
- Software
- Cost components
- Technology or R&D, Personnel, Operations, Marketing or Sales, Infrastructure
Formedix product offering
Product offeringCore offering
Formedix develops and supplies clinical trial automation software focused on data standardization and CDISC compliance. Its platform helps pharmaceutical, biotech, and CRO organizations design clinical studies, build compliant case report forms, validate datasets, and generate submission-ready deliverables for FDA, PMDA, and NMPA regulatory authorities. Following its October 2023 acquisition by Certara Inc., Formedix's technology has been integrated into Certara's Pinnacle 21 Enterprise software platform.
Product overview
Formedix was acquired by Certara in October 2023. Formedix's technology and expertise in clinical trial automation, data standardization, and CDISC compliance was integrated into Certara's product portfolio. The combined offering centers on Pinnacle 21 Enterprise, a platform-plus-modules architecture that provides end-to-end clinical data standardization from study design through regulatory submission. The platform includes core modules for Clinical Metadata Repository, Clinical Trial Design, CRF Design/EDC Build, External Data Exchange, Clinical Data Validation, Issue Management, Define.xml generation, Reviewer's Guide creation, and SDTM Specification Management. Pinnacle 21 Enterprise is offered alongside a free Community version for basic validation needs.
Differentiator
Problem solved
Functional benefit
Products and services
- Pinnacle 21 Enterprise Clinical data standardization software platform that enables clinical teams to standardize, validate, and harmonize data for submission-ready deliverables, achieving conformance with CDISC standards for FDA, PMDA, and NMPA regulatory submissions.
- Pinnacle 21 Community Free community version of validation software offering basic validation capabilities, including Validator, Define.xml Generator, Data Converter, and ClinicalTrials.gov Miner tools.
Companies that use Formedix
Customer profileSegments3 records
Ideal customer profiles3 records
Formedix technology and API
TechnologyTechnology focussed Yes
API detail
- Has API
- No
- API docs
- API detail
Core technology
AI maturity
App detail
Integration2 records
Feature3 records
Formedix partnerships and signals
Strategic signalPartnerships
One partnership is on record.
- Certara Inc.coreIn October 2023, Certara Inc. acquired Formedix LLC to enhance its clinical trial automation capabilities through Formedix's data standardization and CDISC compliance expertise. This acquisition strengthened Certara's position in clinical data management and regulatory submission solutions.
Recent moves4 records
Expansion highlights4 records
Formedix competitors and assessment
Company assessmentEmerging players
- Castor: Castor offers a cloud-native EDC platform with built-in data standardization capabilities, increasingly competing with Formedix in the SMB biotech and academic clinical trial segment.
- Saama Technologies: Saama provides AI-driven clinical trial analytics and data management solutions, increasingly overlapping with Formedix's downstream data validation and submission readiness workflow.
- eClinical Solutions: eClinical Solutions offers the elluminate Clinical Data Cloud with integrated EDC, CDISC mapping, and submission analytics — directly competing with Formedix in clinical data standardization for pharma and CRO sponsors.
- OpenClinica: OpenClinica provides open-source and cloud EDC solutions with CDISC-aware data capture, representing an emerging alternative to Formedix for cost-sensitive sponsors and CROs.
Direct peers
- Veeva Systems: Veeva's Vault CTMS and Vault EDC compete in the same clinical trial data management space, with Formedix explicitly integrating with Veeva Vault via its CRF Creator module to serve overlapping pharma/CRO customers.
- Anju Software: Anju Software provides a suite of clinical trial applications including EDC, CTMS, and data management modules, competing directly with Formedix's platform in mid-market pharma and CRO segments.
- Clario: Clario (formed from the merger of Bioclinica and ERT) delivers eCOA, imaging, and clinical trial endpoint solutions with a focus on data quality and regulatory submission readiness, overlapping with Formedix's regulatory submission positioning.
- Medidata Solutions: Medidata (a Dassault Systèmes company) offers the Rave EDC platform and adjacent clinical trial data management solutions, including CDISC validation capabilities, serving the same pharma, biotech, and CRO customer base as Formedix.
- ArisGlobal: ArisGlobal's LifeSphere platform offers clinical trial data management, regulatory information management, and safety solutions — addressing the same pharma R&D and submission workflows as Formedix.
- Oracle Health Sciences: Oracle's Clinical One platform provides unified clinical trial data capture, management, and submission solutions for large pharma — directly competing with Formedix's standardization and CDISC compliance offerings.
Market position
Strengths5 records
Weaknesses5 records
Competitive moat3 records
Key risks6 records
Key highlights6 records
Customer concentration
Formedix social profiles
Digital presenceFormedix compliance and trust
Trust signalCompliance1 record
Formedix financial estimates
Financial estimateRevenue estimate
Valuation estimate
Formedix leadership team
Management profileNumber of profiles
Profiles4 records
Formedix funding detail
Funding detailFunding overview
Funding rounds
Investors
Funding detail is available on the Subscription and Enterprise plan.Contact sales →
Formedix M&A and investment
M&A and investmentM&A
Investments
M&A and investment is available on the Subscription and Enterprise plan.Contact sales →
Frequently asked questions about Formedix
What does Formedix do?
Formedix develops and supplies clinical trial automation software focused on data standardization and CDISC compliance. Its platform helps pharmaceutical, biotech, and CRO organizations design clinical studies, build compliant case report forms, validate datasets, and generate submission-ready deliverables for FDA, PMDA, and NMPA regulatory authorities. Following its October 2023 acquisition by Certara Inc., Formedix's technology has been integrated into Certara's Pinnacle 21 Enterprise software platform.
Is Formedix a public or private company?
Formedix is a private company. It is classified as corporate owned and is currently acquired.
When was Formedix founded?
Formedix was founded in 2000. It employs 11 to 50 people.
Where is Formedix based?
Formedix is headquartered in Burlington, United States, in the North America region.
Who are Formedix's main competitors?
Emerging players on record are Castor, Saama Technologies, eClinical Solutions and OpenClinica. Direct peers are Veeva Systems, Anju Software, Clario, Medidata Solutions, ArisGlobal and Oracle Health Sciences.
Does Formedix have an API?
No public API is recorded for Formedix.
What industry is Formedix in?
Formedix's product category is Clinical Trial Data Standardization Software. Its primary akta.pro industry code is HLAGAKAA, Regulatory Strategy & Global Submissions (IND/CTA/NDA/BLA/MAA), with a secondary code of HLAGACAL, Site Data Management Support (EDC/Source/SDV Readiness). Its NAICS code is 541512 and its SIC code is 7372.