Caidya was launched as a unified brand in 2022, formed through the merger of dMed and Clinipace — two CROs with complementary geographic strengths — and has since grown through strategic investment and acquisition into a mid-sized global CRO headquartered in the United States. The company’s corporate history reflects a deliberate strategy of cross-border capability building, beginning with Clinipace’s founding in 2004, a series of acquisitions establishing European and Asia-Pacific footholds between 2009 and 2015, dMed’s founding in China in 2016, the dMed–Clinipace merger in 2021, and the Caidya rebrand in 2022. In 2024, the company appointed Barbara Lopez Kunz as Chief Executive Officer to lead its next phase of growth. In 2025, Caidya received a USD 165 million strategic growth investment from Rubicon Founders. In 2026, Caidya announced a strategic combination with Simbec-Orion, a specialist early-phase CRO, creating an integrated offering spanning first-in-human studies through to registration.

The company’s primary client base is small to mid-sized biotech and biopharma innovators, for whom Caidya positions itself as an embedded development partner rather than a transactional vendor. It also serves mid- to larger-sized pharmaceutical companies through Functional Service Provider (FSP) and hybrid delivery models. Caidya’s cross-border infrastructure — with long-standing operations in China providing access to large and diverse patient populations — is a differentiating operational asset for sponsors conducting global studies. The company’s global presence spans North America, Europe, Asia-Pacific (including mainland China), and Latin America.

Key Products and Services

Clinical Development Strategy

• Early Phase Development — study design, first-in-human strategy, Phase I and Phase II protocol development, and regulatory planning for investigational new drug (IND) and clinical trial applications (CTAs) across global markets
• Phase II/III — protocol design, global site strategy, adaptive study design, and end-to-end management of late-phase and pivotal trials
• Regulatory Strategy — regulatory affairs consulting for FDA, EMA, NMPA, and other health authorities; submission strategy, agency meeting preparation, and orphan drug designation support
• Medical Affairs — publication planning, medical information management, and scientific communication strategy
• Post-Marketing Solutions — Phase IV studies, real-world evidence generation, and post-marketing surveillance

Clinical Trial Delivery

• Clinical Operations — site identification, selection, and management; investigator and site training; on-site and remote monitoring; risk-based quality management (RBQM); and central monitoring
• Study Start-Up — feasibility assessment, protocol optimisation, site contracting and budgeting, IRB/Ethics Committee submissions, and regulatory package preparation
• Trial Feasibility — global site and patient population feasibility analysis drawing on the company’s cross-regional site networks
• Project Management — dedicated project leadership with full accountability for timelines, budgets, risk management, and sponsor communication
• Medical Monitoring — medical safety review, adverse event assessment, protocol deviation management, and Data Safety Monitoring Board (DSMB) support
• Clinical Data Management — eCRF design, data entry guidelines, discrepancy management, medical coding (MedDRA and WHO Drug), CDISC compliance (SDTM, ADaM), and database lock
• Biometrics — statistical analysis plans (SAP), sample size calculations, randomisation schedule development, interim and final statistical analysis, and reporting
• Medical Writing — clinical study reports (CSRs), regulatory submissions, investigator brochures (IBs), informed consent forms (ICFs), and publications
• Regulatory Services — CTA and IND submissions, amendment management, and agency correspondence across all covered markets
• Pharmacovigilance — adverse event processing, safety database management, expedited reporting, periodic safety update reports (PSURs/DSURs), and signal management
• Quality Assurance — GCP audits, vendor qualification, SOP management, CAPA development, and inspection readiness support

Service Models

• Full-service CRO — end-to-end trial management and delivery
• FSP (Functional Service Provider) — dedicated staffing and embedded teams for specific functional areas
• Hybrid — combination of full-service management and FSP resourcing adapted to sponsor needs

Technology and AI

• AI-enabled clinical trial operations, with stated principles governing responsible and transparent use of AI tools across data management, project oversight, and operational decision-making
• Integrated clinical technology ecosystem encompassing EDC, CTMS, eTMF, eCOA, and IRT platforms selected and managed on behalf of sponsors

Therapeutic Expertise

Oncology and Haematology, Cardiovascular-Metabolic, Rare Disease, Paediatrics, Gastroenterology, Nephrology, Dermatology, Ophthalmology, Cell and Gene Therapy, Neurology, Immunology, and Infectious Disease.

Caidya occupies a differentiated position in the mid-tier CRO landscape, built around a specific capability that few competitors of comparable size can replicate: genuine cross-border operational depth spanning the United States, Europe, and China within a single organisational structure. This is not an outsourced or partnered China capability — it is an owned operational heritage, originating from dMed’s founding in 2016 and reinforced through the 2021 merger with Clinipace. For biotech sponsors seeking to run global programmes that include China as a development market or patient recruitment geography, this is a practically meaningful differentiator. The 2026 strategic combination with Simbec-Orion — a specialist early-phase CRO with Phase I unit infrastructure — is particularly significant, as it extends Caidya’s coverage upstream into first-in-human studies and clinical pharmacology, creating a more complete development continuum and enabling sponsor relationships to begin earlier and extend further through to registration. Backed by a USD 165 million growth investment and with experienced executive leadership in place, Caidya is positioned as a growth-stage CRO building toward greater scale whilst retaining a client-engagement model calibrated to the needs of innovative mid-sized biotech sponsors.