Professional Clinical Trial Research Team
Professional, high quality and efficient service in line with international standards
Deep professional knowledge, rich industry experience, long-term perspective, global thinking solutions
Full-process Clinical Trial Technical Services
We offer full-process services, including Biostatistics, Modelling and Simulations, Clinical Pharmacological, Meta-analysis, Randmization, Data Management and Pharmacovigilance.
Electronic Clinical Trial Integration Platform
EDC、IWRS 、PVS、ePRO， offering technical support for high-quality clinical trial data
Integrated Modeling & Simulation Solution
Maspectra™ is a one-stop integrated workstation that enables model-informed drug discovery (MIDD).
Our Services
Efficient operation, rigorous academic research ability, deliberate compliance procedure
Randmization
Randomization Plan, IWRS, Drug blinding, Blood sample blinding, etc
Data Management
eCRF/ database building, data management, medical coding, data reviewing, etc
Biostatistics
Statistical Design、Sample size Estimation、DMC/Interim Analysis、ISS/ISE Analysis、IND/NDA Statistical Support、Statistical Monitoring, etc
Medical Affairs
Clinical Development strategy formulation, Protocol Design and Writing, CSR writing, Medical Monitoring, Medical Review, etc
Pharmacovigilance
Safety Database Set Up、SAE Management、SUSAR Submissions、DSUR/PSUR、RCP/RMP, etc
Systematic Review
MBMA、Meta Analysis
Modeling and Simulations
PopPK、(PopPK/PD)、E-R、PBPK、QTc Analysis、Translational Medicine, etc
Clinical Pharmacological
PK Analysis,PD Analysis, BE Analysis, FE Analysis, DDI Analysis , Material Balance and Biotransformation Analysis, etc
Products
Electronic Clinical Trial Integration Platform, Technical Guarantee of high quality clinical trial data
DaS Trial can realize the integration functions of data collection, drug management, biological computing, modeling and simulation, randomized and blinding, electronic diary , image acquisition, pharmacovigilance, standardized document submission, etc. also it can realize the technical process of remote patient participation in the trial, support patient-centered, and provide direct drug delivery solutions to patients. It is an essential tool for sponsors to monitor the safety of subjects and data quality, and is the solution for the full implementation of DCTs.
The Modeling and Simulation Studio (Maspectra) covers many modules required for MIDD, including PK, PD, PK/PD, BE, Statistics, PBPK, CTS, etc., which is an essential integral solution for biomedical research and development, teaching, and scientific research.
The new MIDD model can greatly improve the efficiency and success rate of drug research and development, shorten the research and development cycle, and reduce the cost of clinical trials. Maspectra is your best choice
Maspectra™
DaS Trial®
Customers
Study Sites
Studies
Subjects
Technology leader
Led by well-known experts, professional and stable talent team, strategic R & D strategy, model guidance, rapid promotion
Professional platform
Independent research and development of electronic clinical trial integration platform, system interoperability, data sharing, simplify management, improve efficiency
Rich in experience
Deeply engaged in the clinical trial industry, helped a number of innovative drugs successfully launched, the project covers various disease fields, widely praised, trusted and respected by customers
Reliable quality
Perfect quality system, in line with international standards, certified to ISO9001 and ISO27001, audited by domestic and foreign regulatory agencies and professional teams for many times