Investigator-Initiated Clinical Trial Services
Discover a world of possibilities
Discover a world of possibilities with Porton Advanced as we extend an invitation to explore our unparalleled suite of services, meticulously crafted for cell engineering Investigator-Initiated Clinical Trials (IIT), Investigational New Drug (IND) applications, even Phase 1/2 and NDA/BLA endeavors.
IIT areas we can assist with:
- Document preparation, submission, and approval from local authorities
- Connecting with local authorities and medical institutions
- Supporting the review of IIT study protocols
- Preparing documents as a CDMO partner to medical institutions for project approval and NHC registry review
- Finding reliable CRO and medical writing partners
Conducting IIT
Proven Track Records: We have extensive CMC experience and have completed 5 IIT projects (50+ batches with a 100% release success). Additionally, we have 5 ongoing Phase I/II projects (190+ batches scheduled within 2 years).
State-of-the-Art Facilities: Porton Advanced Solutions LLC is headquartered in NJ, USA and offers two state-of-the-art GMP facilities in Suzhou, China with a total 215,000 square feet. We have cell engineering-12 independent suites (2 for infectious donors), Viral Vectors- 10 production suites- (50-2000L), Plasmid – 2 independent suites (50L*2), Process Development & cGMP Production, Aseptic Fill and Finish, as well as Analytical development and Quality Control and more.
Strategic Partnerships: We have established strategic alliances with key stakeholders and provide end-to-end IIT support from selecting principal investigators, hospitals, recruiting patients, EC (ethics committee) submission, and HGRAC (Human Genetic Resources Administration of China) submission, enabling us to leverage our resources and networks effectively to accelerate your projects/clinical trials.
Time and Cost Savings: Opting to conduct Investigator-Initiated Trials (IIT) and seek Investigational New Drug (IND) approvals in China, while simultaneously applying for both NMPA and FDA approvals, offers substantial cost and time savings. With our proven track record, two of our customers succeeded in obtaining both NMPA and FDA IND approvals, and we presently have 2-3 customers in the process of applying for both NMPA and FDA IND approvals.
Frequently Asked Questions
What are the key differences between IITs and Industry-sponsored trials (ISTs)?
| Type of Trials | Investigator-Initiated Trials (IITs) | Industry-Sponsored Trials (ISTs) |
| Feature | NHC Pathway (IITs) | NMPA Pathway (ISTs) |
| Regulatory Authority | National Health Commission (NHC) | National Medical Products Administration (NMPA) |
| Initiation | Initiation Initiated by individual investigators or hospitals or pharmaceutical, biotech or medical companies Initiated by pharmaceutical, biotech or medical companies | Initiation Initiated by individual investigators or hospitals or pharmaceutical, biotech or medical companies Initiated by pharmaceutical, biotech or medical companies |
| Purpose | Primarily for scientific research | Focused on new drug approval, marketing and commercialization |
| Approval Process | Approval Process Less stringent; requires compliance with ethical review and current good manufacturing practices (CGMP), although the exact standards and flexibility may vary across provinces. More rigorous; requires Investigational New Drug (IND) application and approval from NMPA, followed by pivotal trials and New Drug Application (NDA) approval through the Center for Drug Evaluation (CDE) of the NMPA. | More rigorous; requires Investigational New Drug (IND) application and approval from NMPA, followed by pivotal trials and New Drug Application (NDA) approval through the Center for Drug Evaluation (CDE) of the NMPA. |
| Benefits | Offers more flexibility and can provide valuable early human data on drug safety and efficiency that can support regulatory submissions. | Generally follows a more traditional clinical trial framework |
What are the benefits of conducting IITs in China compared to other regions?
China is emerging as a leading destination for IITs, offering:
- Lower Costs – Clinical trials in China are more cost-effective than in the U.S. or Europe.
- Large Patient Population – Accelerating patient recruitment and enrollment.
- Advanced GMP Facilities – Ensuring high-quality clinical materials for trials.
- Stronger network of abundant experienced PIs and health clinics.
- Multiple IIT cases to support licensing decisions of big pharma (AZ vs. AbelZeta , J&J vs. Legend).
At Porton Advanced, we help investigators leverage these advantages, offering world-class GMP facilities in China, regulatory expertise, and seamless execution support to drive IIT success.
What are the challenges faced by investigators in IITs, and how can they be overcome?
Investigators often face:
- Regulatory Complexity –Navigating multi-agency approval processes
- Limited Funding – Securing financial funds for further research
- Patient Recruitment Issues – Finding eligible participants quickly.
Porton Advanced has strong strategic alliances with key stakeholders in the industry, such as principal investigators, hospitals, regulatory agents, etc. We can provide a full range of IIT services with our partners, from regulatory consulting to patient recruitment solutions, ensuring investigators can focus on research while we handle the complexities.
How can Porton Advanced help our clients conduct IITs?
- Connect with local authorities and medical institutions
- Produce samples for IITs
- Support in reviewing the IIT study protocols
- Prepare documents as a CDMO partner for medical institutions for project approval and NHC registry review
- Support in finding reliable necessary CRO and medical writing partners
What experience does Porton Advanced have in supporting successful IITs?
Porton Advanced has a proven track record of IIT success, including:
- Extensive CMC experience
- 15 IIT projects (140+ batches, 100% release success rate, including 3 for US clients)
- 11 NMPA IND approvals, 4 FDA IND approvals and 1 Medsafe lND approval
- Currently supporting 5 ongoing Phase 1/2 projects.
- 300+ batches of GMP manufacturing
With world-class GMP facilities, strategic regulatory expertise, and an unwavering commitment to clinical success, Porton Advanced is the trusted partner for IIT excellence.