Our Approach: A Seamless Extension of Your Team
We prioritize your goals, operating as a fully integrated partner to bring life-changing therapies to patients.
Aligned Partnership
We deliver flexible, patient-centric solutions, solving issues proactively, reducing risk, and delivering the high-quality data you need to make critical decisions.
Expertise-Driven Insights
Our experience in executing complex trials and our adeptness in key therapy areas bring valuable insights to fuel your future breakthroughs from day one.
AI-Powered Execution
Our proprietary AI platform underpins every operational activity, ensuring speed, data quality, and predictive insights that keep your trial on track and on budget.
Our Global Team & Reach
Our team is comprised of leading oncologists, investigators, and operational experts with extensive experience overseeing trials across the globe.
We empower our clients to reach patients no matter where they are. This distinct global reach, combined with deep local knowledge of culture, physicians, and trial sites, allows us to identify the best-suited sites and clinicians to meet your trial's unique needs. Our operational model ensures we can provide high-touch site management and real-time support around the clock, functioning as a true global partner.
Deep Therapeutic & Indication-Specific Experience
Our expertise is proven. We have direct, hands-on experience in the most complex and challenging areas of oncology research.
Solid Tumors
- Advanced and early-stage solid tumors
- Basal Cell Carcinoma
- Bladder Cancer
- Bone Cancer
- Brain Cancer (incl. Glioblastoma)
- Breast Cancer (incl. TNBC)
- Cervical Cancer
- Colorectal Cancer
- Endometrial Carcinoma
- Gastrointestinal Cancer
- Head and Neck Cancer
- Hepatocellular Carcinoma
- Liver Metastases
- Melanoma
- Neuroendocrine Tumors
- Non-Small Cell Lung Cancer (NSCLC)
- Ovarian Cancer
- Pancreatic Cancer
- Prostate Cancer
- Renal Cell Carcinoma
- Sarcoma
- Small Cell Lung Cancer
- Squamous Cell Carcinoma
- Thyroid Cancer
Hematologic Malignancies
- Acute Lymphocytic Leukemia (ALL)
- Acute Myeloid Leukemia (AML)
- Chronic Lymphocytic Leukemia (CLL)
- Diffuse Large B-cell Lymphoma (DLBCL)
- Hodgkin's Lymphoma
- Multiple Myeloma
- Myelodysplastic Syndrome (MDS)
- Other Non-Hodgkin's Lymphomas
- Other rare solid tumors
Comprehensive Clinical Development Services
We offer a full spectrum of services to support your program from initial strategy to final clinical study report.
1. Strategy & Trial Design
- ▶Protocol Design and Writing Support: Oncologist-led development of robust protocols focusing on clear objectives, appropriate endpoints, and dosing rationale to minimize complexity and ensure scientific integrity.
- ▶Early Clinical Development Strategy: Comprehensive planning for early-phase studies, including guidance on clinical pharmacology, ethnic sensitivity consultation for global trials, and PK/PD modeling.
- ▶Complex & Adaptive Trial Design Expertise:
- First-in-Human (FIH) dose-finding and dose-escalation studies
- Bayesian design for dose escalation
- Two-stage design for cohort expansion
- Basket and Umbrella trials for targeted therapies
- Seamless Phase I/II and Phase II/III designs
- Combination therapy and factorial designs
- Bridging studies for global registration
- ▶KOL & Investigator Consultation: Leveraging our extensive global network of Key Opinion Leaders and top-tier investigators to refine study design and align with current clinical practice.
2. Global Execution & Site Management
- ▶Dedicated Feasibility & Site Identification: Our specialized department supports the identification of the best-performing trial sites globally, ensuring rapid startup and access to the right patient populations.
- ▶Patient-Centric Recruitment & Retention: We combine technology with established relationships (KOLs, patient advocacy groups) to find and retain patients, focusing on reducing patient burden to ensure high-quality data collection.
- ▶Expert Site Engagement & Support: We provide "high-touch" site management without creating undue burden. Our clinical and medical specialists engage and educate site staff, which is critical for complex modalities like cell and gene therapy, ensuring effective study execution and logistics.
3. Medical & Safety Oversight
- ▶24/7 Medical Monitoring Services: Our team provides real-time support for site interactions, medical data review, patient surveillance, and management of a global 24/7 emergency call service.
- ▶Comprehensive Safety Assessments: Rigorous review of Serious Adverse Events (SAEs), including medical review and relationship assessment, to ensure patient safety and regulatory compliance.
- ▶Management of Adverse Events of Supportive Care: Specialized expertise in managing treatment-related toxicities such as cancer breakthrough pain, cachexia, chemotherapy-induced toxicities, tumor lysis syndrome, and immune-related adverse events (irAEs) like Cytokine Release Syndrome (CRS) and neurologic toxicity.
- ▶Governance Committee Management: Full leadership and support for Safety Review Committees, ensuring independent and expert oversight of your trial.
- ▶Clinical Study Reports (CSRs): Expert authoring of comprehensive CSRs for regulatory submission.
Led by Industry Pioneers
Our services are delivered by a team with a proven track record of success in both clinical development and technology innovation.
Dr. Ashok Srivastava
President & Chief Medical Officer
A board-certified oncologist with 17+ years of experience leading over 130 global oncology trials. Dr. Srivastava's expertise in trial design, medical monitoring, and regulatory strategy is foundational to our operational excellence.
Elias Tharakan
Chief Executive & Technology Officer
The architect of an eClinical platform used in over 1,000 studies, leading to dozens of drug approvals. Elias drives our technology-first approach, ensuring our AI-powered tools deliver unparalleled efficiency and data quality.