Understanding Complexity
Our deep therapeutic expertise aligns with the innovators we serve. We understand the intricacies of your science and the patients who need it most.
Deep Scientific Acumen
Our team is made up of oncologists and investigators who understand the culture, patients, physicians, and trial sites essential for success in complex studies.
Unwavering Patient-Centricity
We design and execute trials that reduce patient burden and incorporate the needs of people with rare diseases and their caregivers, especially pediatric patients.
Agility for Innovators
As a nimble, expert-led organization, we are built to support emerging and mid-sized biopharma, acting as a true extension of your team to navigate complexity together.
Deep Dive into Our Core Focus Areas
We provide integrated, end-to-end support tailored to the unique demands of each therapeutic area.
1. Oncology & Hematology
We grasp the intricacies of oncology studies, from the ever-changing regulatory landscape and novel study designs to personalized treatment options.
- 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
- 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
Specialized expertise in managing adverse events and treatment-related toxicities, including:
- ►Cancer breakthrough pain
- ►Cancer cachexia
- ►Chemotherapy-induced toxicities
- ►Tumor Lysis Syndrome
- ►Immune-related Adverse Events (irAEs)
- ►Cell & Gene Therapy toxicities (CRS, ICANS)
2. Rare Diseases & Pediatrics
Our team has successfully advanced over 210 rare disease studies with nearly 19,500 patients across more than 2,900 sites worldwide.
We address every challenge head-on, from designing protocols with appropriate inclusion/exclusion criteria to finding eligible patients in sparse populations and securing experienced sites.
We have a dedicated focus on the unique needs of pediatric trials. We carefully examine the pediatric patient journey to balance ease of participation for children and their caregivers with the requirement to collect high-quality data.
We leverage technology and our established relationships with KOLs and patient advocacy groups to find patients. We reduce patient burden through patient-centric practices to maximize retention.
3. Cell & Gene Therapy
Our leadership team has direct clinical development and BLA filing experience with approved CAR-T cell therapies, including playing a key role in the approval of AUCATZYL® (Obe-cel).
Expert site guidance is critical for cell or gene therapies. We ensure sites can effectively handle complex study execution, logistics, and patient monitoring from leukapheresis to post-infusion follow-up.
Deep expertise in monitoring and managing the unique toxicities associated with cell therapies, such as Cytokine Release Syndrome (CRS) and Immune Effector Cell-Associated Neurotoxicity Syndrome (ICANS).
4. Additional Therapeutic Areas
While oncology and rare diseases are our core focus, our deep clinical development and operational capabilities extend to other complex areas, including:
- ►Dermatology
- ►Cardiovascular
- ►Ophthalmology
- ►Immunological Rare Diseases
- ►Rare Genetic & Blood Disorders
- ►Rare Neurological Diseases
Led by Therapeutic Area Pioneers
Our expertise is embodied by our leadership, who have dedicated their careers to advancing therapies in these complex fields.
Dr. Ashok Srivastava
A "hands-on" global leader in oncology and hematology with 17+ years of experience. Dr. Srivastava has led over 130 trials and is an expert in cutting-edge modalities, including CAR-T, ADCs, and oncolytic viruses, with multiple successful BLA/NDA filings.
Elias Tharakan
A visionary technology executive who developed specialized solutions for complex oncology trials. Elias's platform provided real-time quality data for adaptive trials with thousands of subjects, contributing to dozens of approvals.
Partner with True Expertise
Contact us to discover how our deep therapeutic knowledge can de-risk your program and accelerate your path to success.