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About Us

Helpclin Data Service Co., Ltd., is committed to providing data management, statistical programming, biostatistics services faster to pharmaceuticals companies. With the professional and highly experienced team, the core member has more than 9 years of industry experience. Helpclin offers high-quality services in compliance with CDISC standards and the standard operating procedure (SOP). Helpclin is a good partner and provider of high-quality services within tight timelines and budgets.

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Our Service
Data Management

Documents development

(e)CRF design

Database setup, validation and go live

External (central laboratory) data management

Data double entry and correction

Third party auidt

Data quality control

SAE reconciliation

Medical coding

Database maintenance and access managements

Query Management

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Biostatistics

Sample size calculations

Statistical sections of the protocol

Randomization plan

Statistical analysis plans/report

PK and PK/PD analyses

Safety data analyses

Meta analysis

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SAS Programming

Analysis datasets specifications development

Derived datasets creation

Program Tables, Figures and Listings (TFL)

QA/QC the datasets and TFL

CDISC services (SDTM, ADaM and Define.XML)

Support eCTD submission

Patient summaries for narratives

Support data management

ISS(SCS)/ISE(SCE) analysis

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Our Advantages
高效专业
Efficient and Professional

We have the systematic and completed SOP, and standardized SAS codes to deliver services faster, more efficient and cost-effective than ever thought possible.

数据安全
Data Security

The servers with the features of flexibility in resource acquisition, unified authentication, security & reliable, IP core protection and dynamic extensions, ensure data security.

质量控制
Quality Control

The complete procedures of quality control guarantee the highest quality in all our services.

国际视野
Global Configuration

We are fully regulatory compliant with CFDA, FDA and other regulatory agencies.

Our Dynamic
Partner
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