Services
What we can offer our clients!
We offer our clients cost efficient and flexible solutions for various needs and situations. Our specific expertise in China and vast experience in the pharmaceutical field makes us an ideal partner for you when entering China for M&A activities, research, marketing and sales activities.
CRO Services
- Introduction of clients to Key Investigators at Chinese hospitals and clinics
- Start up, performance and reporting of phase II, III, and IV clinical trials
- Applications for regulatory SFDA and IRBs for clinical trials in China
- GCP training of investigators and monitors
- Monitoring of clinical trials according to GCP-ICH
- Registration of medical device products in China
Medical device - China market research
Astrom Research International can offer Medical Device companies market access to China. We perform analysis of the Chinese market for Medical Device and competitor intelligence reports pertaining to your therapeutic area. We can also direct you with partner identification and regulatory strategy.
Our team of business analysts are located in Shanghai and cover all major geographic areas in China. Our service is highly priceworthy since we work according to domestic Chinese business standards.
Consulting Services
The consulting services of Astrom Research International mainly focus on partner identification and negotiation in China on behalf of clients in Europe and the US.
- M&A Advisory services for EU / US CROs and domestic CROs in China
- Identification and negotiation with suitable partners in China
- Recruiting and training of clinical domestic research staff (PMs,CRAs)
- Organisation of Investigator meetings, conferences, seminars and study-visits
- Introduction to central and regional government authorities and key officials
- Translation services English / Chinese (business and clinical research)
Medical Writing
Astrom Research International offers clients qualified Medical Writing projects including but not limited to.
- Submissions to Competent Authorities, Ethics Committees / liaison
- Investigator’s Brochure (IB)
- Clinical Study Protocols
- Integrated Clinical Study Reports
- CTDs
- Translations of Medical Communications
- Abstracts and Manuscripts
- SOPs
- Patient Information / ICF
- SAE, SUSAR, Annual Safety Reports
- Tailor made Training sessions
Dr. Astrom has published multiple articles on international clinical research and is member of the advisory editorial board of several international journals.