CRO

菜单

Full-Service Clinical Research Solutions

Clinical Data Management

Database Development

Create database specifications:

Global EDC Settings
Live Database User Roles
Time and Events Schedule
Study Forms
Study Checks

eCRF development

Edit check development & programming

Perform study database testing including creation of a UAT Testing Plan and Final UAT Report

Database build management and oversight

Data Management

Create and maintain the Data Management Plan (DMP) including specification of Manual Data Review Listings

Create eCRF Completion Guidelines (eCCGs)

Provide training for sites, Sponsor, and the clinical team as it pertains to the database and eCRF Completion

Perform data review/cleaning and query generation and resolution

Perform database access administration

Perform dictionary coding

Perform SAE reconciliation

Perform external data reconciliation of PK and PD data including creation of Data ransfer Agreements

Perform formal data review cycles

Liaise with Sponsor and any designees

Maintain Data Management study timelines and study related documentation

Data Programming

Create database specifications:

Global EDC Settings
Live Database User Roles
Time and Events Schedule
Study Forms
Study Checks

eCRF development

Edit check development & programming

Perform study database testing including creation of a UAT Testing Plan and Final UAT Report

Database build management and oversight

Biostatistics & Programming

Statistical Analysis Plan

SAP development includes individual studies as well as ISS/ISE.

Develop SAP

Prepare TFL Shells

Update SAP and Shells

Sign off SAP and Shells

SDTM

SDTM services includes CDISC compliant studies and legacy

studies in submission format.

aCRF SDTM annotation

SDTM specifications

SDTM mapping

Independently validate SDTM domains

Pinnacle 21 validation

Create Define.xml

Create Study Data Reviewers Guide (SDRG)

Convert SDTM domains to transport file

SDTM transfer/Dry run and final SDTM transfers

ADaM

ADaM production applies to individual studies as well as ISS/ISE.

ADAM specifications

Create ADaM datasets Independently validate ADaM datasets

Pinnacle 21 validation

Create Define.xml

Create Analysis Data Reviewers Guide (ADRG)

Convert ADaM datasets to transport files

ADaM transfer/Dry run and final ADaM transfers

Tables, Listings, Figures (TFLs)

TFL production applies to individual studies and ISS/ISE.

Create TFLs for CSR according to SAP and shells

Independently validate TFLs

Data quality review, data reconciliation and consistence checking

Dry runs and final transfer of TFLs

Data Monitoring Committee (DMC)

Create and Review DMC charter

Develop/Review SAP and TFL Shells

Set up firewall protected DMC study folder; Update database for DMC meeting; Create analysis datasets and TFLs: 2 sets of TFLs: Pooled and by scrambled Dummy Treatment. Perform independent validation.

Develop presentation slides for closed DMC session

TFLs delivery in sFTP encrypted method to IDMC committee members

Taking meeting minutes

Bioresearch Monitoring Program (BIMO)

BIMO preparation applies to all NDA and sNDA submission.

Clinical Study-Level Information Independently validate TFLs

A Comprehensive and Readily Located Table Listing All Clinical Sites That Participated in Clinical Studies

Table Listing All Entities to Whom the Sponsor Has Contracted Clinical Study-Related Activities

Subject-Level Data Line Listings by Clinical Site (Previously known as OSI listings (FDA Office of Scientific Investigations)

Summary-Level Clinical Site Dataset

Clinsite.xpt

Define.xml

BIMO Data Reviewer's Guide (bdrg.pdf): Recommended

BIMO Reviewer's Guide

Pre-IND&IND Services

U.S., China, and Southeast Asia Regulatory Submissions

Communication and Fast-Track Application

Supplemental Applications

Gap Analysis of Regulatory Submissions

Preparation of Regulatory Submission Documents

Clinical Development Strategy Formulation

Preparation of Regulatory Electronic Files and eCTD

Regulatory Consulting

Medical Services

IND and NDA Strategy

Clinical Development Plan

Study Protocol Design

Medical Monitoring

Medical Training

Study Report Writing, etc.

Phase I-IV Clinical Operation

Clinical Operation

Project Management

Clinical Monitoring

QA Service

PV Service

Site Start-up, Subject Management

Ethics Submission and Follow-up

Document Management, Data Collection

Study Vendor Management

Drug Supply Management

Site Close-Out

Full-Service Clinical Research Solutions

We support the entire clinical development lifecycle—delivering customized, end-to-end services that accelerate timelines and ensure regulatory success.

Our approach integrates

Scientific Rigor
Operational Excellence
Regulatory Expertise

Our Services Include

Early-Phase Strategy & Planning
Clinical Trial Management
Regulatory Submissions
Commercialization Support

With global infrastructure and regional insight, PanaCRO ensures efficient, compliant, and high-quality outcomes—bringing therapies to patients faster.