Oncology

The Present and Future of Oncology

Approvals for oncology drugs is around 5% - less than half compared to other treatment areas. The rate of failure is increasing, especially beyond Phase II trials.
New regulatory requirements for the development of regenerative medicine in oncology demands stakeholders to be even more conscious of safety throughout the development process.
Recently, drug development in Asia has become increasingly active. Preparedness to differences between Asian countries is critical to development.

Remedy Group's Features of Oncology

• Providing full service consultations - from the initial stages of development all the way to regulatory authority submission.

  1. Development Strategy
  2. Communicating with Regulatory Authorities
  3. Protocol Design
  4. ICF Design
  5. Site Selection
  6. Submission

  Our Consultation Services

  • Clinical Trial Design
  • Site Selection
  • Site Re-Selection
  • PRT/ICF Review
  • Development Strategy
  • Submission Package
  • Clinical Trial Organization
  • Test Design in Japan
  • Attendance to Global Meetings
  • Support and Attendance to Meetings with PMDA
  • Marketability Survey on New Endoscopic Operation
  • Consultation of development Strategy on Oncolytic Virus

  Responding to All Intractable Cancers

  • Malignant Pleural Mesothelioma
  • Neuroendocrine Tumor
  • Hodgkin's lymphoma
  • Multiple Myeloma
  • Aplastic Anemia
  • Bladder Cancer
  • Non-Small Cell Lung Cancer
  • Others

  Breakdown of Pharmaceutical Cimpanies

  • Japan Domestic Pharmaceutical Companies: 50%
  • Foreign Pharmaceutical Companies: 30%
  • Foreign Start-ups: 20%

• CRAs specialized in oncology are assigned to the trials to increase the probability of a successful trial.

  Led by experts with over 20 years of working experience in clinical trials for oncology, over 90% of our projects have achieved milestones in oncology.

• Full scope of clinical trials across Asia.

• We have received superior reviews globally for its highly accurate feasibility studies capable only through its proprietary network.

• Oncology focused Employee Training

  We have implemented a one-of-a-kind certification program for developing Oncology specialists under the guidance of Dr. Nagahiro Saijo (globally recognized KOL). CRAs who have obtained Remedy’s specialized certifications are assigned to clinical trials.
  Our MSLs are highly qualified with extensive on-site experience and expertise in Oncology.

  Multilingual
  Support

  1. Training for employees inexperienced in Oncology

     Basic Training in Oncology

  2. Training in the Basics of Molecular Targeted Agents to Development Trends of New Drugs

     Training in Molecular Targeted Agents

  3. Treatment characteristics for each Cancer

     Training by Cancer Type

  4. Focused MSL training

     MSL Training

  5. Follow-Up Assessments and Self-Learning

     Provision of E-Learning Materials