Oncology
We understand the needs and expectations of small and mid-size biotechs, guiding you through dose escalation/expansion studies and global pivotal trials, offering insight every step of the way.
Understanding the complexity of oncology studies
From early phase development, FIH, dose escalation in phase 1, safety signal detections and trend analysis to regulatory approval, oncology studies require specific clinical expertise, insight, and diligent patient-centric monitoring to ensure success.
We understand oncology study intricacies: from the ever-changing regulatory landscape to novel and increasingly complex study designs to personalized treatment options.
Our team is made up of oncologists and investigators who understand the culture, patients, physicians and trial sites, with extensive experience overseeing trials globally.
Key capabilities include:
- Strategic business development for state-of-the-art treatments including the patient pathway and competitive landscape
- Medical oncology protocol design and writing support, early clinical development strategies, dosing rationale,
- Clinical pharmacology including ethnic sensitivity consultation and PKPD modeling
- Dedicated feasibility department to support identifying the best trial sites globally.
- Medical monitoring services – Medical Data Review, Safety Review Committees Management, Patient Surveillance
- Site interaction and real-time support
- Global 24/7 emergency call service
- Safety assessments including SAE, medical review & relationship assessment
- Clinical study reports
- Leading PI or renowned KOL consultations regarding study design and clinical practice
Highlights of our oncology experience include:
Solid Tumors
- Advanced and early stage solid tumors
- Basal cell carcinoma
- Bone cancer
- Bladder cancer
- Brain cancer
- Breast cancer
- Cervical cancer
- Colorectal cancer
- Endometrial carcinoma
- Gastrointestinal cancer
- Glioblastoma multiforme
- Head and neck cancer
- Hepatocellular carcinoma
- Liver metastases
- Melanoma
- Neuroendocrine tumors
- Non-small cell lung cancer
- Ovarian cancer
- Pancreatic cancer
- Prostate cancer
- Renal cell carcinoma
- Sarcoma
- Small cell lung cancer
- Squamous cell carcinoma
- Thyroid cancer
- Other rare solid tumors
Hematologic Tumors
- Acute lymphocytic leukemia
- Acute myeloid leukemia
- Chronic lymphocytic leukemia
- Hodgkin Lymphona
- Diffuse large B-cell lymphoma
- Other non-Hodgkin Lymphoma
- Multiple myeloma
- Myelodysplastic syndrome
Trial Design and Management
- First-in-human dose finding
- Bayesian design for dose escalation
- Two-stage design for cohort expansion
- Basket and umbrella trials
- Seamless design such as Phase I/II and Phase II/III
- Combination therapies and factorial designs
- Bridging studies
Management of Adverse Events and Supportive Care
- Cancer breakthrough pain
- Cancer cachexia
- Chemotherapy-induced toxicities
- Tumor lysis syndrome
- xImmune-related adverse events
- CGT toxicities such as cytokine release syndrome and neurologic toxicity
Outside of traditional chemo and targeted therapies, we also have outstanding experience in new therapies such as:
Immuno-oncology
From developing the clinical development plan for your immuno-oncology product to designing customized studies and delivering multiple stages of clinical trials from early to late phase, we bring extensive experience in immune-oncology development. Our services include optimizing the study dose design for Phase I trials, selecting appropriate target populations, and rationalizing sample size for multiple stage trials. We also strengthen the safety management, including immune-related adverse events from the medical and clinical operational perspective. We select experienced investigators and sites, closely monitoring safety indicators, especially for immune-related toxicities.
Cell and Gene Therapy (CGT)
With extensive experience in autologous and allogeneic CGTs, we understand the unique clinical and logistics requirements of CGT trials. We help design customized studies, including selecting indications (hematological or solid tumors), optimizing dosing frequency (single or multiple dosing) and dosing interval. We also focus on the safety assessment and the preparation for cell infusions such as premedication, intensively monitoring and managing severe safety events such as cytokine release syndrome and neurotoxicity.
Vaccines
Our experts have extensive experience designing, implementing, and executing clinical trials involving preventive, adjuvant and therapeutic vaccines and understand the specific guidance for trials in the space provided by regulators including the FDA.
Medical monitoring services
Our medical monitoring teams deliver protocol-related medical training, study start-up, 24/7 coverage, full protocol review, help evaluate the subject eligibilty, and conduct medical data review on a per-patient listings (TFL) basis, including query and coding reviews. In addition we conduct patient surveillance, including signal detection and safety trend analysis, performed in real time and assisted by Clarity, our unique visualization tool.
Shared knowledge is power
We understand oncology study intricacies: from the ever-changing regulatory landscape to novel and increasingly complex study designs to personalized treatment options.
Speak to a global expert
Ready for the next step in your drug development journey? Learn more about how our personalized solutions can help you enable better healthcare outcomes.
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