Clinical Development Support
Clinical development of pharmaceutical products is divided into two types depending on the target market: domestic development in the home country and multinational development for international expansion. In the case of development in Japan alone, clinical trials are conducted in a manner that meets domestic regulations in Japan. In the case of development for Japan and other markets, clinical trials are conducted in accordance with international standards. When considering strategies for developing clinical development of pharmaceutical products, especially in international development, a great deal of experience, knowledge, negotiation skills, communication skills, etc. are required. However, for many companies, it is difficult to provide all the necessary roles in-house.
PPBIZ's experienced and knowledgeable consultants provide a high level of support for your company's drug development, ensuring that your development strategy and actual development work are fit for purpose and efficient.
Domestic Development Support
PPBIZ provides support for the establishment of development strategies, contracted development work, and licensing applications necessary for the clinical development of pharmaceutical products in Japan.
We provide consulting services to create added value for the product under development or to advance its development.
- Evaluation of drug candidates (verification of issues in clinical development)
- Verification of non-clinical studies (pharmacology, pharmacokinetics, toxicology, etc.) necessary to initiate clinical trials
- Preparation of investigational new drug summaries
- Market research in the target disease area for clinical trials
- Survey of experts in the target therapeutic area
- Negotiation with experts in clinical development and management of expert meetings
- Preparation of clinical trial protocols
- Preparation necessary for clinical trials (preparation of investigational drugs, securing contractors for drug analysis, selection of clinical CRO, etc.)
- Clinical trial notification (CTN) and CTD preparation
- Project management, support for management of clinical trials
- Management and establishment of safety evaluation committee
- Data quality management (see Data Management)
Overseas development support
We provide the necessary support for conducting clinical development of pharmaceutical products overseas. When a Japanese company conducts clinical trials overseas, a local representative (pharmaceutical affairs consultant) may be required in some countries. In addition, it is recommended to hire a local medical expert (medical consultant) due to the differences in medical conditions in the clinical site in the country where the clinical trial is conducted.
PPBIZ has helped many Japanese companies conduct clinical trials in Europe and the United States.
We initiate clinical development projects and manage them by securing the necessary resources to facilitate clinical trials in the target countries.
- Evaluation of drug candidates (review of the medical situation in the target country and challenges in clinical development)
- Validation of Nonclinical Studies (Pharmacology, Pharmacokinetics, ADME, Pharmacodynamics, Toxicology) necessary to initiate clinical trials
- Creation of Investigator's Brochure (IB) or Investigational Medicinal Product Dossier (IMPD)
- Market Assessment in the target therapeutic area of the clinical trial
- Survey Key Opinion Leaders (KOLs) in the target therapeutic area
- Negotiation with KOLs in clinical development and management of Investigator Meetings, etc.
- Creation of protocols for clinical trials (study of protocols for international development and protocols tailored to regional needs)
- Preparation necessary for clinical trials (preparation of investigational drugs, securing contractors for drug analysis, selection of clinical CROs, etc.)
- Negotiation with CRO (Project Management, Data Management, Biostatistics, Drug Product/IMPD Management, etc.)
- IND/CTA submissions to regulatory authorities, preparation of CTDs as application documents
- Support for project management and clinical trial management
- Establishment and management of Safety Review Committee
- Data Quality Management (see Data Management)
Marketing Support
We provide support for planning, planning, and promotional activities related to sales and marketing necessary for drug development.
In drug development, it is necessary to narrow down the target of which market and what disease to target. While the target disease is narrowed down based on the expected efficacy, information on whether the new drug will be accepted in the market and whether there are any competing drugs is also necessary when considering sales. Furthermore, if there are treatment guidelines for the drug in the market, including other related drugs, it is necessary to investigate whether there is room for the new drug to be included in the guidelines.
PPBIZ, together with its overseas partners, provides information on the medical situation in the country, the availability of existing drugs, and information on competing drugs. Currently, we are not directly involved in post-sales marketing strategies, but we can introduce you to overseas market research companies.
- Assistance in researching the medical situation overseas
- Assistance in understanding the number of patients with specific diseases in overseas markets
- Assistance in researching the prevalence of pharmaceuticals in overseas markets