Clinical CRO Service:

We provide a comprehensive range of services in clinical development. We provide Phase I to Phase IV clinical development services & BE (Bioequivalence), for products including pharmaceuticals, biologics, and medical devices. With expertise spanning all major therapeutic areas, we deliver the unique blend of an experienced team, combined with the creativity, responsiveness, and customer centric-focus of a highly nimble organization. This forward-thinking approach has allowed us to work on a variety of projects ranging from first-in-human products to marketed drugs and devices.
Early Clinical
Our experience enables us to tailor our approach to each project. We offer a broad range of services geared towards accelerating the drug development process while maintaining quality. Our team’s experience and expertise enable us to provide our clients with the high-quality clinical development experience.
Our focus is on Phase I trials of innovative drugs, bioavailability, and bioequivalence studies. The unit became a certified clinical trial institution by the NMPA. Our center is fully staffed with full-time researchers, physicians, and nurses to ensure care is provided for patients. We have managed trials with normal healthy volunteers (NHV) and patients participating in endocrine, oncology, respiratory and geriatrics studies.
We are able to provide our clients a flexible, innovative approach to comprehensive early stage drug development from lead candidate selection to proof of concept. We combine world-class CRO services with cross-functional program management and global regulatory expertise to support IND applications. Consider us if you are looking for full-service solutions including clinical pharmacology, FIH and proof-of-concept trials to support and conduct comprehensive early phase clinical services.
Our primary service areas include:

1. Bioequivalence
2. Bioavailability
3. FIH single dose and multiple dose ascending study
4. Proof-of-concept
5. Pharmacodynamics (PD)
6. Pharmacokinetics (PK)
7. Drug-drug Interaction
8. Confirmatory PK study to support China NDA for Category 3 drugs
9. PK in Special Populations
Clinical Operations
Our operational services involve a collaborative strategic design process from product inception to regulatory approval, throughout early clinical trial to New Drug Application. The commitment of our project managers is not limited to our sponsors; they are also equally devoted to patients, physicians, investigators, and regulators. When assembling a team for your study, we take into consideration our trial experience and therapeutic expertise to ensure the right match is designed for your trial.
We provide high level of management and clinical development services for clinical trials across all phases, as well as for medical devices, IVDs and vaccines. In the past few years,Rochi Pharma has built solid and long-term partnerships with our customers by delivering projects on time with high level quality. We help customers implement their product development strategies. Our study start-up team’s delivery has been commended by several sponsors for the lead in this industry
We offer full-time operational are able to offer our customers 24/7 support.
We provide a full range of clinical services, including：
1. Project management
2. Site selection and activation
3. Patient recruitment services
4. Clinical monitoring & site management
5. Cross-regional strategic regulatory consulting
6. Trial Master Files (TMF) management
7. Quality Control services
Biometrics (Data Management, Programming, and Biostatistics)
With decades of experience and extensive industry knowledge, Rochi Pharma provides accurate and integrated clinical data while adapting to customer trial’s specific data requirements within established timelines and budget parameters. We provide all-rounded clinical information services. Our biometrics team is made up of 200 professionals with a breadth of knowledge and rich experience in all clinical projects. 40% of our team members have experience with overseas projects while 35% of them have participated in oncology projects.
With sound structure and training systems, our data management team is experienced in foreign pharmaceutical factories and CROs. Trained to guarantee high project cooperation, reliable delivery quality, and good customer relations, the team is both efficient and professional.
Biostatistics, Programming and Data Management services
1. Biostatistics consultation
2. Clinical development plan and strategies
3. Medical Affairs Support/Observational Studies
4. Statistical Analysis Plans (SAPs)
5. Case report form (CRF) design based on CDASH
6. Establishment and application of EDC database
o Medidata RAVE EDC and related modules
o IBM eCOS and related modules
o OmniComm TrialMaster
o Inform
o DataLabs
o OpenClinica
o iMedNet
o Medrio
o Taimei EDC0 and 5.0.
7. IRT databases build-up and navigation
o Medidata Balance
o IBM Randomization, Inventory
8. CTMS database build-up
o Medidata CTMS
9. Medical coding

oMedDRA
oWHODrug
10. DM status report and listings including study specific KPIs and trends
11. Study risk monitoring centered quality control
12. Medical Monitoring List
13. Patient Profile Report and Patient Narrative
14. Observational Studies/RWE
15. Data Mining, Meta-analyses
16. Data warehousing and Data Integration
17. Expert review and statistical evaluation
18. CDISC submission standards, including legacy data conversion:
o SDTM
o ADaM
o XML
o Data Auditor Handbook
19. Conversion of traditional data to CDISC standard data such as SDTM, ADaM
20. CSR/SAR production
21. Submission
o ISE/ISS
o eCTD
22. DMC support
23. Analytical services that provide comprehensive summaries of safety and efficacy
24. FDA Annual Safety Report
25. US Clinical Trials Registry (gov) and European Clinical Trials Registry (EudraCT) data submission

Medical Monitoring/PVG
Medical Specialties / Scientific Consultant
Our medical team is composed of tenured MDs and KOLs with experience spanning the therapeutic spectrum and medical expertise in study design, protocol development, medical monitoring, and scientific affairs. Dr. Alfonso Alanís, the Global Head of Medical Affairs holds over 35 years’ experience in the clinical development industry, across all major therapeutic areas and phases with a particular expertise in enrolling ethnically-balanced populations into clinical trials. Our medical team is primed to offer the necessary guidance to project teams to ensure a successful drug development process, on time and on budget. Our team members are based in North America, China, and throughout the EU.
We provide a range of services, including but not limited to:
1. Medical Specialties / Scientific Consultation
2. Study design
3. Protocol development
4. Medical & Safety Monitoring
5. Project Team Training and Support
6. Medical data review and trend analysis
7. Pharmacovigilance
8. Clinical Study Report (CSR)
Pharmacokinetics/Pharmacodynamics (PK/PD) Analysis：
Our clinical pharmacology team brings a wealth of experience in renowned PK labs and more than 5+ years with preclinical and clinical PK studies. Our team can provide clinical study design, PK/PD modeling and PK analysis reports.
Clinical Pharmacology services including:
1. Bioequivalence study (i.e., HVD, NTI, and endogenous drugs)
2. Phase I clinical study (i.e., FIH, SAD, MAD, food effect and DDI)
3. Phase III clinical study (Study design for Pop PK）
4. PK parameter calculation (NCA and Compartmental analysis）
5. PK SAP and PK analysis report
6. PK modeling and PK/PD modeling
Medical & Scientific Writing:
The qualifications of our writers include postdoctoral, doctoral, and master’s degrees with an average of 5+ years of medical writing experience in a wide variety of indications and research types. Our writers compose documents from multiple data sources for a variety of audiences while maintaining a consistent style, voice, and message from beginning to end. We employ writers with strong project management and negotiation skills, who work with the sponsor to ensure their feedback is reconciled and documents are true to timelines, ultimately producing clean and cohesive copy.
1. Protocols
2. Clinical Study Reports
3. Investigator Brochures
4. Regulatory submissions
5. Publications
6. Lab manuals
7. Dosing instructions
8. Informed Consent Forms
9. Research Handbook
Pharmacovigilance:
Our pharmacovigilance (PV) team has experience in working on more than 100 regional and global projects. Our team has 5+ years of experience in working at both large and small biopharma companies and CROs. With the desire to always put the customers’ needs first, the pharmacovigilance team merges their expertise, premier professionalism, and commitment to quality in order to guide customers through a successful and safe development journey, from discovery through submission in both drug and medical devices.
Clinical pharmacology services including:
1. PV system setup
2. Clinical safety data management
3. Post marketing safety data management
4. PV database system service
5. Signal detection and evaluation
6. Development Safety Updated Reports (DSUR)
7. Risk Management Plan (RMP)
8. Periodic Safety Updated Reports (PSUR)
9. PV training and consultation
Regulatory Affairs
We are committed to accelerating the development and marketing of medical and health products for the benefit of patients. We can provide registration and regulatory consulting services covering the whole life cycle of medical and health products, including pharmaceutical products (small molecules, biologicals and natural products), medical devices, diagnostics and dietary supplements. Our services cover China, the United States, Canada, and major countries and regions around the world.
Our regulatory experts have more than 10 years of experience with a thorough understanding of the evolving local regulatory environment and comprehensive product development expertise, good communication with the regulatory authorities. We aim to accelerate the process of bringing products to market smoothly and efficiency with correct develop plan, appropriate regulatory strategy and high quality dossier.
We provide a range of registration and regulatory consulting services, including but not limited to:
Regulatory consulting:
1. Consultant of product development and registration
2. Feasibility assessment
3. Regulatory strategy and plan
Medical and health products registration:
1. Dossier writing and gap analysis
2. Package compilation and publish (including eCTD)
3. Regulatory Agent / Regulatory Contact Services
4. Investigational Applications (Pre-IND, IND, Pre-Submission requests, IDE, ITA, CTA.)
5. Marketing Applications （Pre-NDA , NDA, BLA, ANDA, 510K, DeNovo 510(k), PMA, MAA,)
6. Drug Master Files
7. Post Marketing Submission
8. Supplements
9. Orphan drug designation
10. Fast track designation
11. Breakthrough therapy designation
12. Pediatric investigational product applications (PREA, PIP)
13. Scientific avice submission
14. Annual reports
15. Trial registration

Quality System Management & Consulting:
We are dedicated to ensuring our quality management system is focused on controlling any risks identified for your study, ensuring integrity of data and foremost the protection and safety of patients. We accomplish this by incorporating the principles of quality management, GCP guidelines, and applicable regulatory authority requirements within our standard operating procedures, work instructions, employee training curriculum and internal processes.
Our Quality Assurance program includes compliance audits, procedural and regulatory compliance, and operational synergy between all departments. This operational synergy ensures protocol compliance, identifies risks to quality, and helps identify study specific training for your clinical trial.
The quality team has 5-10 years of working experience in the field of clinical research, and in-depth knowledge and practical experience in the operation and management of clinical research projects, quality management, quality assurance and handling regulatory inspections. The quality team has performed more than 50 project audits in the past several years and has successfully passed more than 8 regulatory inspections.