Real World Data to Real World Evidence

Real-world data (RWD) is no longer an afterthought—it’s being integrated earlier in the development lifecycle to: ✅ Map disease progression ✅ Inform trial design ✅ Recruit patients ✅ Benchmark therapies ✅ Identify gaps in access and representation This shift is particularly impactful in rare and heterogeneous cancers, where traditional trials often struggle with participant diversity […]
Webinar: Applying Patient-Level Data & AI in Rare Diseases & Oncology

We’re excited to announce our upcoming webinar on October 7, 2025! Clinakos Inc. invites you to an exclusive webinar on Applying Patient-Level Data & AI in Rare Diseases & Oncology. Rare diseases and oncology represent some of the most complex therapeutic areas with the highest unmet medical needs. ⚕️Drug development and commercialization in these fields […]
Leukemia and Lymphoma Awareness Month

September is Leukemia and Lymphoma Awareness Month! Every story starts with one step—and sometimes, that step is noticing something just isn’t right. At Clinakos, we’re proud to spotlight Marc Lees’ journey—an unforgettable reminder of how courage and community fuel hope when facing blood cancer. Marc, an energetic retail manager and devoted family man, was caught […]
FDA Orphan Drug Approvals in 2025

In the first half of 2025, the FDA approved 16 novel therapies, with 10 of these being orphan drugs for rare diseases—demonstrating a clear focus on this area. To put this into perspective, orphan drugs made up 47% of novel therapies in 2024 and 49% in 2023. This year, if the current trend continues, 2025 […]
From Margins to Mainstream: Including Underrepresented Patients in RWE

Underserved. Underdiagnosed. Underrepresented. That’s the reality for millions of patients missing from real-world evidence. They don’t show up in the claims. They’re undercoded in EHRs. They’re overlooked in traditional cohort designs. And when they’re invisible to your data, they’re invisible to your strategy. At Clinakos, we bring these patients into focus—with purpose. ✅ Integrated Patient […]
Auto-inflammatory awareness month

August is Autoinflammatory Disease Awareness Month! Did you know that autoinflammatory diseases are rare, often misunderstood conditions where the immune system causes inflammation by attacking the body itself? These diseases can be difficult to diagnose and manage, impacting patients and families in profound ways. A major survey analyzed data from 1,043 patients across 52 countries […]
Spinal Muscular Atrophy Awareness Month

Spinal Muscular Atrophy (SMA) is a rare genetic disorder that affects the motor neurons in the spinal cord, leading to muscle weakness and loss of movement. It impacts thousands of families worldwide, often striking in infancy or early childhood, though it can also appear in adulthood. Meet Vaia—diagnosed with SMA and severe spinal complications as […]
2024 Global “AI in Oncology” market report

Clinakos Inc. is proud to be recognized as a key player in shaping the future of AI-driven oncology alongside market leaders including Nvidia, ConcertAI, Oracle, PathAI, CureMatrix, Tempus, GE Healthcare, Siemens Healthineers, Medrtonic, Roche, Insilico Medicone, and others. According to the latest AI in Oncology Market report from MarketsandMarkets, the global market is set to […]
Unlocking the Power of External Control Arms with Real-World Data

A recent editorial in Frontiers in Drug Safety and Regulation highlights a major shift in clinical research: over 50% of single-arm HTA submissions between 2011 and 2019 included some form of external control data—a clear sign of ECAs’ growing importance for regulatory and payer decisions. ECAs leverage real-world data (RWD)—from electronic health records, patient registries, […]
Myth: “All patient data sources provide the same level of insight for research.”

There’s a common myth floating around, and we are about to break that “Myth: All Patient Data Sources Offer Equal Insights” That’s simply NOT true. In life sciences—especially in Rare Disease & Oncology—data quality isn’t just valuable, it’s transformative. Syndicated or token-linked data misses the depth, accuracy, and agility needed for catering to developing fast-paced […]
