Clinical CRO

Service Scope

        As an early stage focused full service CRO with global quality system, MicroConstants China works closely with our partnering clinical sites to provide early stage clinical trial full services for domestic and international biotech and pharmaceutical companies, including, SAD/MAD/Food effect, PK, BE, and TQT studies in China for their products registration in China and abroad. The company’s clinical operation, data management, biostatistical analysis, and PK bioanalysis departments work closely to ensure smooth execution of client projects following ICH GCP, FDA/OECD GLP, and NMPA relevant guidelines. The company’s proprietary CTMS and LIMS management system allow efficient tracking of project progress. 

        MicroConstants China completed its first BE full service for a major pharmaceutical company in 2010 and has conducted numerous early phase clinical studies for domestic and global pharmaceutical/biotech companies over the years, including FIH study for antibiotics/oncology drugs/anti-clotting drugs, PK studies, BE studies for generics, and TQT studies.
List of Completed BE Projects

Partnering Clinical Sites

        Since year 2009, MicroConstants China has been implementing ICH GCP at clinical sites in China, such as No. 307 Hospital and No. 301 Hospital of PLA, Shanghai Mental Health Center, Guangzhou TCM Hospital, etc. and established network of clinical trial centers who are certified by China NMPA to conduct Phase I safety/tolerability, PK, Bioequivalent, Bioavailability, Drug-drug (food) interactions, and Phase II/III/IV clinical studies for novel and generic drugs. 
Following is a partial list of our partnering clinical trial centers.
City/Region Clinical sites
Beijing No. 307 Hospital of PLA, No. 301 Hospital of PLA, Beijing Hospital, No.3 Hospital of Beijing University, No. 302 Hospital of PLA, Chaoyang Hospital, General Hospital of Air Force, Tongren Hospital, No.6 Hospital of Beijing University, Beijing Children’s Hospital, Shijitan Hospital, etc.
Shanghai Huashan Hospital, Shanghai Mental Health Center, Shanghai Public Health Center, etc. 
Other Cities in China Queen Mary Hospital of Hong Kong, Xiangya Hospital, Shenyang General Hospital of PLA, Chengdu General Hospital of PLA, Guangzhou TCM Hospital, Wuhan Tongji Hospital, etc.
USA Anaheim Clinical, Integrium, West Coast Clinical Trial Center, etc.

Cardiac Safety/eCOA

        MicroConstants China has established partnership with eResearch Technology (ERT), a global leader in providing high quality patient safety and efficacy endpoint data collection solutions for clinical drug development, to provide marketing and in-country support in Greater China region for ERT's cardiac safety studies and eCOA studies. MicroConstants China assists ERT with project assurance functions, including logistics support, first line of support (help desk), bilingual presentation at IM meetings, and on-site training, that are necessary to ensure proper use of ERT equipment.
ERT Safety & Efficacy.Ensure patient safety and measure compound effectiveness by driving high-quality data. With ERT Safety & Efficacy, you can improve data quality with integrated solutions that allow you to eliminate electronic clinical outcome assessment (eCOA) complexity so you can move ahead quickly, monitor every heartbeat with precision and ensure safety, demand data quality and breathe easy in your clinical trials, and deliver imaging results without the typical human bias. 
        ERT is a global data and technology company that minimizes uncertainty and risk in clinical trials so that customers can move ahead with confidence. With nearly 50 years of clinical and therapeutic experience, ERT balances knowledge of what works with a vision for what’s next, so we can adapt without compromising standards. Powered by the company’s EXPERT® technology platform, ERT’s solutions enhance trial oversight, enable site optimization, increase patient engagement and measure the efficacy of new clinical treatments while ensuring patient safety. Since 2014, more than half of all FDA drug approvals came from ERT-supported studies. Pharma companies, biotechs and CROs have relied on ERT solutions in 10,000+ studies spanning more than three million patients to date. By identifying trial risks before they become problems, ERT enables customers to bring clinical treatments to patients quickly — and with confidence.
Centralized Cardiac Safety Solutions  ERT provides for the collection, interpretation and distribution of ECG data and images during clinical trials in all phases of the clinical research process. ECGs are administered at the local investigation site using a standard set of protocols and homogenous equipment. The digital ECG data is then transmitted to the ERT centralized cardiac safety laboratory where it is subject to a standardized set of operational processes. ERT’s Cardiac Safety solutions, including its proprietary EXPERT® technology platform, provide for workflow-enabled cardiac safety data collection, interpretation and distribution of ECG data and images as well as for analysis and cardiologist interpretation of ECGs performed on research subjects in connection with our customers’ clinical trials. 
        As part of ERT’s Cardiac Safety solutions, ERT offers continuous digital 12-lead ECG recording and longer-term Holter recording devices. For continuous digital 12-lead ECG recording, the 12-lead ECG signals are recorded onto compact flash memory cards and submitted to ERT for processing. ERT’s Cardiac Safety solutions also include Extensible Mark-up Language (XML) data delivery, which provides for the delivery of ECGs in a format compliant with the United States Food and Drug Administration’s XML standard for digital ECGs for submission to the FDA ECG Warehouse. ERT also provides ECG equipment through rental and sales to customers to perform the ECG recordings and give them means to send such recordings to ERT. ERT’s portal product, MyStudyPortal™, provides sponsors and investigator sites with the ability to order supplies, gain real time reports and respond to queries via a secure web portal. 
Electronic Clinical Outcomes Assessments (eCOA) ERT offers solutions for the electronic capture of self- reported data from patients, clinicians and caregivers that directly or indirectly measure how patients feel or function and can be used to determine whether or not a drug has been demonstrated to provide a treatment benefit. These solutions are referred to as patient reported outcomes (PRO), clinician reported outcomes (ClinRO) and observer reported outcomes (ObsRO). ERT also offers an intelligent suicide monitoring and prevention program (AVERT™). ERT’s eCOA solutions offer higher quality data with accurate timestamps and real-time data access for logical branching and edit checks to confirm data accuracy compared to existing practice of using paper based diaries and assessments. eCOA provides less variable and more reliable data enabling smaller trials and better scientific conclusions. 
        ERT’s eCOA solutions include both products and services for clinical trials. ERT manufactures devices which include handheld electronic diaries, tablets, spirometers that are designed exclusively for clinical research and enable high resolution, remote collection, memory and automatic data transmission. ERT also provides an Interactive Voice Response (IVR) system accessible through standard telephone lines and offer device customization, worldwide logistics and our in-house global and local support to ensure comprehensive and efficient trial management. ERT’s sells expertise in COA Strategy, Instrument Selection / Modification / Development, Instrument Migration from Paper to Electronic Format, and Regulatory Support.