Investigator-Initiated Clinical Trial Services
Discover a world of possibilities
Advanced therapies, including cell therapy, gene therapy, and nucleic acid therapy, are regulated in two ways: by the National Health Commission (NHC) as a Category III medical technology for clinical use, or by the National Medical Products Administration (NMPA) as a pharmaceutical product. For therapies regulated under the first category, Investigator-Initiated Clinical Trials (IITs) are conducted to gather safety and efficacy human data by companies, academic institutions, and hospitals. Although they are non-registrational clinical trials, high-quality IIT studies can be used as supplementary materials for IND submission, licensing decisions, or raising financial rounds.
Explore the world of possibilities with Porton Advanced as we invite you to discover our exceptional suite of services, meticulously designed for Investigator-initiated Clinical Trials (IITs), Investigational New Drug (IND) applications, and even Phase 1/2 and NDA/BLA endeavors.
Integrated IIT services to solve pain points encountered by global clients
The lack of local connections, expertise, and regulatory knowledge makes it challenging to conduct IITs in China, especially for our clients based outside the country. To address this issue, we are partnering with reputable Contract Research Organizations (CROs) to jointly provide comprehensive IIT services. Our collaboration will cover everything from GMP manufacturing, IIT application, connecting with PIs, patient recruitment to clinical data collection and analysis.
- For GMP production, please click here for more information:
Why choose to work with us?
Proven Track Records: Porton Advanced has extensive CMC experience and has completed 18 IIT projects and acquired 17 IND approvals with 300+ successful runs. Additionally, we have 5 ongoing Phase I/II projects.
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 of 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.
Here is a comment from one of our sponsors in the United States:
“We are confident that through close collaboration with Porton Advanced, Eureka is well-positioned to accelerate our key pipeline programs, supported by Porton’s robust and reliable manufacturing capabilities.”
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) |
| Dual-Track Regulation Mode | “Medical techonologies” track | “Drug” track |
| Regulatory Authority | National Health Commission (NHC) | National Medical Products Administration (NMPA) |
| Initiation | Hospitals or pharmaceutical, biotech or medical companies | Hospitals or pharmaceutical, biotech or medical companies |
| Purpose | Primarily for scientific research | Focused on new drug approval, marketing and commercialization |
| Approximate Timeline | Less stringent Four to eight months to connect with principle investigators (PI), clinical centers and apply for ethic review and OHGRA The exact standards and flexibility may vary dependent on district and clinical centers. | More rigorous One and a half years for IND application Four to eight months to connect with principle investigators (PI), clinical centers and apply for ethic review and OHGRA |
| GMP manufacturing | Madantory | Mandatory |
| Benefits | Offers more flexibility and can provide valuable early human data on drug safety and efficiency. | 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 with a guaranteed recruitment rate.
- Advanced GMP Facilities – Ensuring high-quality clinical materials for trials.
- Stronger network of experienced PIs and health clinics.
- Multiple IIT cases to support licensing decisions of big pharma (AZ vs. AbelZeta1, J&J vs. Legend2, AZ vs. Esobiotech3)
At Porton Advanced, we help investigators and sponsors 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 (e.g. NHC, HGRAC)
- 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
- Entire Import Process and reliable cold-chains/shipping setup with clinical centers
What experience does Porton Advanced have in supporting successful IITs?
Porton Advanced has a proven track record of IIT, IND CMC, and clinical-phase projects, including:
- Extensive CMC experiences
- 18 IIT projects (3 for US clients)
- 12 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.
Reference:
- AstraZeneca PLC. Imfinzi-based regimen demonstrated statistically significant and clinically meaningful improvement in event-free survival in resectable early-stage gastric and gastroesophageal junction cancers. Available at: https://www.astrazeneca.com/media-centre/press-releases/2025/imfinzi-improved-efs-in-early-stage-gastric-cancer.html. Accessed April 2025.
- E药经理人. 传奇高管揭秘CAR-T成功获批前后，与强生合作细节大曝光 https://mp.weixin.qq.com/s/p5Z8SwKgrxUsepeGSYb3Sg Accessed April 2025.
- EsoBiotec SA. EsoBiotec Begins Clinical Trial of In Vivo BCMA CAR-T Candidate ESO-T01 for Multiple Myeloma. https://www.esobiotec.com/esobiotec-doses-first-patient-in-investigator-initiated-trial-of-in-vivo-bcma-car-t-candidate-eso-t01-for-multiple-myeloma/. Accessed April 2025.