Clinical Development Strategy & Study Design Vendors

Vendors supporting clinical development planning, protocol design, feasibility, site and country strategy, enrollment forecasting, trial budgeting, biostatistics, statistical programming, and study design decisions before or at the start of execution.

Workflows in this category

Within3 is a software platform, data provider, and service provider for KOL mapping, medical insights, social listening, and virtual engagement.
Evidence-backed workflow match
Matches KOL Mapping & Expert Identification
“Within3 applied network analytics to map the entire disease community, not just the client’s known experts. The analysis revealed an “invisible college” of 52…”
Source: within3.com

Also offers: Medical Insights Management, Social Listening & Online Conversation Insights, +1 more

H1 is a software and data intelligence platform providing HCP/HCO data, KOL identification, and study feasibility and site selection.
Evidence-backed workflow match
Matches Study Feasibility & Site Selection
“H1 distributes, collects, and structures feasibility questionnaire responses across sites. This allows you to move faster with consistent, decision-ready data.”
Source: h1.com

Also offers: KOL Mapping & Expert Identification, Healthcare Professional & Organization (HCP/HCO) Data

TriNetX is a data and intelligence provider offering real-world datasets, protocol planning, feasibility analysis, and evidence research.

Products: TriNetX LIVE, TriNetX Dataworks +5 more

Evidence-backed workflow match
Matches Protocol Design & Optimization
“Build and test inclusion/exclusion criteria impact on patient populations, identify optimal sites, and reduce protocol amendments before they occur.”
Source: trinetx.com

Also offers: Study Feasibility & Site Selection, Real-World Data Platform, +1 more

ZS is a life-sciences consulting, technology and data firm providing commercial strategy, market access, medical affairs and clinical planning services.

Products: ZAIDYN, ZS Trials.ai +3 more

Evidence-backed workflow match
Matches Study Feasibility & Site Selection
“Unify trial, site and patient data to evaluate feasibility and select the right countries, sites and investigators from the start.”
Source: zaidyn.zs.com

Also offers: Segmentation, Targeting & Call Planning, Medical Insights Management, +5 more

Veristat is a specialty CRO providing biostatistics, clinical data management, and regulatory strategy and writing services.

Products: InStat, CoAuthor

Evidence-backed workflow match
Matches Protocol Design & Optimization
“Protocol design, endpoint and comparator selection, KOL and advisory panel development, and adaptive design approaches built to meet your trial's objectives.”
Source: veristat.com

Also offers: Biostatistics & Statistical Programming, Full-Service Clinical Trial Execution (CRO Services), +3 more

IQVIA is a CRO and technology provider delivering clinical trials, real-world evidence, commercial intelligence and safety operations.

Products: IQVIA Vigilance Platform, SmartSolve +4 more

Evidence-backed workflow match
Matches Protocol Design & Optimization
“We can help you streamline your protocols for success with IQVIA’s unparalleled data — leveraging AI, automation and data captured at the point of care so you can design smarter…”
Source: iqvia.com

Also offers: Full-Service Clinical Trial Execution (CRO Services), Real-World Data Platform, +6 more

Althian Clinical Research is a boutique CRO supporting clinical trials, regulatory submissions, safety, data, and real-world studies in Mexico and LATAM.
Evidence-backed workflow match
Matches Protocol Design & Optimization
“…Before a protocol is finalized, we conduct a thorough operational feasibility review to assess whether the design is realistic given the available patient population, site…”
Source: althian.com

Also offers: Full-Service Clinical Trial Execution (CRO Services), Marketing Authorization & Lifecycle Submission Support, +3 more

Anju Software is a software and services provider for clinical trial management, electronic data capture, medical information, and publication management.

Products: IRMS MAX, TA Scan +1 more

Evidence-backed workflow match
Matches Study Feasibility & Site Selection
“TA Scan’s Trial Feasibility Flex is a powerful analytics tool, allowing teams to quickly and easily combine high quality global trial intelligence, with their own operational…”
Source: anjusoftware.com

Also offers: Clinical Trial Management System (CTMS), Electronic Data Capture (EDC), +2 more

Celerion is a CRO and laboratory services provider supporting clinical development, bioanalysis, biometrics, trial operations, and regulatory submissions.

Products: ClinQuick

Evidence-backed workflow match
Matches Protocol Design & Optimization
“Experienced in the ethical and regulatory requirements of North America, Europe and Asia, we offer a global solution to your protocol development needs, from conceptualization to…”
Source: celerion.com

Also offers: First-in-Human (Phase I) Clinical Pharmacology Support, Clinical Trial Bioanalytical & Biomarker Testing, +2 more

Altasciences is an early phase CRO and CDMO providing toxicology, IND-enabling studies, clinical pharmacology, bioanalysis, and drug manufacturing.

Products: Acceleration Platform

Evidence-backed workflow match
Matches Protocol Design & Optimization
“Our clinical pharmacologists perform background research, and consult with research specialists, to ensure we craft the ideal, customized design to meet your POC objectives…”
Source: altasciences.com

Also offers: Toxicology Studies, First-in-Human (Phase I) Clinical Pharmacology Support, +2 more

Axtria is a life sciences software and analytics provider for sales operations, commercial analytics, and real-world evidence.

Products: Axtria SalesIQ, Axtria MarketingIQ +7 more

Evidence-backed workflow match
Matches Protocol Design & Optimization
“Expert-designed and data-informed clinical trial protocol development”
Source: axtria.com

Also offers: Commercial Performance Measurement, Territory Alignment & Roster Management, +4 more

Voisin Consulting Life Sciences provides regulatory, clinical, pharmacovigilance, market access and development services.
Evidence-backed workflow match
Matches Protocol Design & Optimization
“…Tailored clinical protocols design. Acts as an interface between Sponsors and CROs/CMOs, aiding in the selection of contractors with proven success”
Source: voisinconsulting.com

Also offers: Regulatory Development Strategy & Agency Interactions, Market Access Strategy & Launch Planning, +3 more

Halloran Consulting Group is a life-sciences consulting firm providing regulatory strategy, dossier writing, GxP quality, and clinical trial management.
Evidence-backed workflow match
Matches Protocol Design & Optimization
“Our team designs forward-thinking yet executable studies, collaborates with subject matter experts, and develops study synopses and schedules.”
Source: hallorancg.com

Also offers: Regulatory Development Strategy & Agency Interactions, GxP Compliance Consulting, +2 more

Komodo Health is a healthcare data and AI platform for patient journey analytics, real-world evidence and commercial insights.

Products: Healthcare Map, Marmot +9 more

Evidence-backed workflow match
Matches Protocol Design & Optimization
“Test inclusion and exclusion criteria against de-identified patient records to see how each one moves the eligible pool.”
Source: komodohealth.com

Also offers: Real-World Data Platform, Patient Journey & Population Analytics, +1 more

Blue Matter Consulting is a strategic consulting firm providing launch readiness, portfolio strategy, market access, and medical affairs planning.

Products: Twine, Narralytix +1 more

Evidence-backed workflow match
Matches Protocol Design & Optimization
“Design protocols from the start that enhance the patient experience & speed up enrollment”
Source: bluematterconsulting.com

Also offers: Product Launch Strategy & Readiness, Market Access Strategy & Launch Planning, +2 more

Favicon of DCN Dx

CDMO / CMO · +5 more types

DCN Dx is an IVD CDMO and CRO providing assay development, clinical trial operations, regulatory support, and manufacturing services.

Products: miniDxR, MICA-200C +1 more

Evidence-backed workflow match
Matches Protocol Design & Optimization
“Consulting on clinical trial design while ensuring compliance with specific regulatory requirements for IVDs.”
Source: dcndx.com

Also offers: IVD Assay Development, IVD Manufacturing & Scale-Up, +2 more

ProductLife Group is a life sciences consulting and outsourcing group for regulatory affairs, pharmacovigilance, quality and validation, and market access.

Products: D.AI.M.I.

Evidence-backed workflow match
Matches Protocol Design & Optimization
“Protocol design and endpoint selection aligned to EMA and FDA requirements”
Source: plglifesciences.com

Also offers: Regulatory Development Strategy & Agency Interactions, End-to-End Pharmacovigilance Outsourcing, +6 more

WPP Life Sciences Platforms is a software platform and services provider for congress intelligence, KOL engagement, and HCP contracting.

Products: X-Fly, X-Bench +10 more

Evidence-backed workflow match
Matches Study Feasibility & Site Selection
“This balances data-side flexibility with faster reporting deployment. 3. Build in phases, not all at once Rather than attempting to deliver every feature on day one, PRISM is…”
Source: lsp.es.wpp.com

Also offers: Key Opinion Leader (KOL) & Stakeholder Engagement, Medical Insights Management, +3 more

SteepRock is an AI-native data and analytics company offering KOL identification and engagement, grants and investigator-initiated study software.

Products: OLA, OLMS +6 more

Evidence-backed workflow match
Matches Study Feasibility & Site Selection
“Discover the best qualified investigators/sites to achieve your trial recruitment goals.”
Source: steeprockinc.com

Also offers: Key Opinion Leader (KOL) & Stakeholder Engagement, KOL Mapping & Expert Identification, +2 more

Simulations Plus is a drug-development software and consulting provider offering PBPK modeling, pharmacometrics and QSP, and AI-driven drug design.

Products: GastroPlus, MonolixSuite +9 more

Evidence-backed workflow match
Matches Protocol Design & Optimization
“Our protocol optimization methodology translates your complex, scientific and regulatory document into a streamlined, interactive patient journey simulation, including site…”
Source: simulations-plus.com

Also offers: Model-Informed Drug Development (MIDD), PBPK Modeling, +3 more

Alpha Sophia is a healthcare commercial intelligence platform providing claims-based HCP data, segmentation and targeting, and KOL identification.

Products: KOL AI, Alpha Sophia Assistant +3 more

Evidence-backed workflow match
Matches Study Feasibility & Site Selection
“By combining real-world patient volumes with scientific influence scores and institutional mapping, Alpha Sophia allows trial managers to identify the investigators who have the…”
Source: alphasophia.com

Also offers: Segmentation, Targeting & Call Planning, KOL Mapping & Expert Identification, +1 more

Aissel Technologies provides KOL management software for KOL mapping and engagement, congress intelligence and HCP social listening.

Products: konectar, konectar Social +4 more

Evidence-backed workflow match
Matches Study Feasibility & Site Selection
“Clinical development teams rely on tiering to identify the right principal investigators for trials.”
Source: aissel.com

Also offers: Key Opinion Leader (KOL) & Stakeholder Engagement, KOL Mapping & Expert Identification, +2 more

Salesforce Life Sciences Cloud is software for CRM, field medical enablement, medical information, patient recruitment, and patient services case management.

Products: Agentforce Life Sciences, Life Sciences Cloud for Customer Engagement

Evidence-backed workflow match
Matches Study Feasibility & Site Selection
“The Site Management data model helps life sciences organizations identify suitable sites for conducting research studies.”
Source: developer.salesforce.com

Also offers: Life Sciences CRM, Medical Information Software Platforms, +4 more

Favicon of Costello Medical

Agency · +3 more types

Costello Medical is an employee-owned consultancy for literature reviews, economic models, HTA submissions, real-world evidence and medical communications.
Evidence-backed workflow match
Matches Study Feasibility & Site Selection
“Study site identification and selection”
Source: costellomedical.com

Also offers: HTA Strategy & Submissions, Health Economic Modeling, +3 more

Saama is a life-sciences software and services provider offering biostatistics, clinical data management, data integration and AI-enabled analytics.

Products: Smart Data Quality, Smart Medical Coding +7 more

Evidence-backed workflow match
Matches Study Feasibility & Site Selection
“Then Saama built an analytics tool that allowed the customer to quickly identify, qualify and select countries, sites and investigators, as well as conduct ad hoc analyses.”
Source: saama.com

Also offers: Clinical Data Management, Data Integration, ETL & Interoperability, +1 more

Definitive Healthcare is a data and analytics provider offering claims-based RWE, HCP/HCO reference data, and patient journey analytics.

Products: Atlas All-Payor Claims, Atlas Prescription Claims +11 more

Evidence-backed workflow match
Matches Study Feasibility & Site Selection
“Trial Accelerator improves your timeline to FDA approval by identifying the fastest-enrolling sites and investigators.”
Source: definitivehc.com

Also offers: Real-World Data Platform, Healthcare Professional & Organization (HCP/HCO) Data, +2 more

Tunnell Consulting is a life sciences consulting firm providing GxP compliance, regulatory strategy, and technology transfer support.
Evidence-backed workflow match
Matches Protocol Design & Optimization
“…Protocol and Trial Design”
Source: tunnellconsulting.com

Also offers: GxP Compliance Consulting, Technology Transfer, Process Characterization & PPQ, +2 more

Veeva Systems is a life-sciences software and data provider offering CRM, medical information, regulatory, and clinical operations platforms.

Products: Vault CRM, Veeva RIM +6 more

Evidence-backed workflow match
Matches Study Feasibility & Site Selection
“Streamline feasibility, site selection, and site greenlight to execute trials faster.”
Source: veeva.com

Also offers: Life Sciences CRM, Regulatory Information Management (RIM) Platforms, +4 more

Rook Quality Systems provides consulting and research services for medical device quality systems, regulatory strategy, clinical studies, and validation.
Evidence-backed workflow match
Matches Protocol Design & Optimization
“Design your clinical trial for success with strategic regulatory guidance from our experienced team, accelerating your path to market.”
Source: rookqs.com

Also offers: Quality Management System (QMS) Consulting, Medical Device & IVD Regulatory Affairs, +1 more

Lumanity is a life sciences consultancy for market access strategy, health economic modeling, brand positioning and scientific communications.

Products: Lumanity Illuminator, Evidence Illuminator +9 more

Evidence-backed workflow match
Matches Protocol Design & Optimization
“Trial design and protocol optimization”
Source: lumanity.com

Also offers: Market Access Strategy & Launch Planning, Brand Strategy & Positioning, +2 more

Frontage Laboratories is a CRO and CDMO providing bioanalysis, DMPK and ADME studies, toxicology, Phase I support, and drug manufacturing.
Evidence-backed workflow match
Matches Protocol Design & Optimization
“Study design, protocol development, sample size calculation, statistical analysis planning, subject randomization, table and graph design, and report writing”
Source: frontagelab.com

Also offers: Bioanalysis & Biomarker Assay Services, Integrated CDMO/CMO Services, +3 more