Clinical Trial Organization System

Clinical Trial Organization System
The Bindertek Clinical Trial Organization System has been designed specifically for the clinical trial compliance process so that any document can be located in seconds.

System Overview

The system includes the following components and includes a 25% package discount:
  • 6+ pre-formatted 3” binders (Advantage™ Classic 2-Ring or One-Touch™ Classic 3-Ring)
  • 6+ sets of index tabs (pre-formatted or blank)
  • 1 table of contents template (in MS-Word)
  • Several optional accessories, including hole punches, DocuCopy reinforced paper, sheet protectors, and more

System Contents
Binders
The binder colors are specifically assigned to certain categories of documents, making it easier to remember where documents are stored. Categories include: (1) Regulatory, (2) Safety, (3) Correspondence, (4) Equipment, (5) Personnel, (6) Investigational Product, (7) Patient Records (optional).

Index Tab Sets
The system includes pre-labeled or blank index tab sets that make it easy to organize the contents of each binder. The pre-labeled tab sets are numbered (1-15) for all binders, except for Correspondence (labeled by month). The blank tab sets include 10 tabs per set.

Table of Contents
Upon placing your order, you will receive the Table of Contents file via email. Formatted in MS-Word, the color-coded table of contents provides a quick summary of all document file locations. Simply click on each tab, type in the contents, and print when ready.

Optional Accessories
The optional DocuCopy paper includes Mylar-reinforced holes to ensure the Table of Contents cannot tear out of the binder. If you prefer to use your own paper, choose 2- or 3-hole punches instead. Other accessories include sheet protectors, binder envelopes, and CD holders.

System Benefits
25% Package Discount
To receive the 25% package discount, at least one binder in each category (except for Patient Records) and at least six index tabs sets must be purchased. However, you may purchase as many binders, tab sets, and accessories as you wish at a 25% discount.

Optimal Site Efficiency and Storage
Color coding and indexing allow for quick and easy access to any document in seconds. Because the same organization system and color scheme can be used for each study, it will also be much easier to find documents years later when retrieved from storage.

Infinite Expansion
The kit includes enough index tabs for the average study. However, if any binder reaches full capacity, simply start a new one in the same color (with tabs numbered 16-30) to continue adding documents in their proper category.

Easier and Faster Inspections
Monitors appreciate a well-organized, inspection-ready research site. The Table of Contents enables quick and easy document retrieval. The binders require less table space to lay out trial information for monitors and inspectors. The overall system reduces the stress of hosting an inspection and provides evidence of a well-run site.

1) Choose Your Binder System

  • Advantage 2-Ring

    Advantage® 2-Ring (3-inch)

    The Advantage™ Series binder features a smart European design with a rich, yet classic appearance. The innovative design lets you quickly access your files from top or bottom without turning a page. Featuring the most reliable ring mechanism available anywhere, it will save you time and keep your office running efficiently.
    Select Advantage
  • OR
  • One Touch 3-Ring

    One Touch® 3-Ring (3-inch)

    The One-Touch™ Series binder features a fluid, one-touch 3-ring mechanism that allows you to add pages easily and quietly. Featuring a durable ball-and-socket closure, the slanted D-Ring ensures perfect alignment every time without fear of snagging a page.
    Select One Touch

2) Choose Your Binder Quantities

Regulatory

Regulatory

  • - Regulatory Protocols
  • - Enrollment and consent forms
$6.99/unit
Quantity
Safety

Safety

  • - IRB
  • - Safety and Recruiting Record
$6.99/unit
Quantity
Correspondence

Correspondence

  • - Correspondence Records by Month
$6.99/unit
Quantity
Equipment

Equipment

  • - Equipment Records
  • - Lab Certifications
$6.99/unit
Quantity
Personnel

Personnel

  • - Personnel and Training Records
$6.99/unit
Quantity
Investigational Product

Investigational Product

  • - Dispensing and Shipping Records
$6.99/unit
Quantity
Patient Records

Patient Records

  • - Patient Binders
$6.99/unit
Quantity

3) Choose Your Tabs

Alphabetical (A-Z)

Monthly and Numeric Tabs

Prelabelled tabs

+ Pre-labelled tabs
$5.50/unit
$6.50/unit
OR
Blank Write On Index Tabs 10 Tab Set

Blank Tabs

Write your own custom tab labels

+ Blank Tabs
$5.00/unit

4) Add Your Accessories

40 Page Two-Hole Punch40 Page Two-Hole Punch
Note 1
+ 40 Page Two-Hole Punch
$29.00/unit
Quantity
40 Page 3-Hole Punch40 Page 3-Hole Punch
Note 2
+ 40 Page 3-Hole Punch
$38.00/unit
Quantity
DocuCopy Pre-Drilled Paper 20 lb. DocuCopy Pre-Drilled Paper 20 lb.
Note 3
+ DocuCopy Pre-Drilled Paper 20 lb.
$20.95/unit
Quantity
Deluxe U.S. Sheet ProtectorsDeluxe U.S. Sheet Protectors
Note 4
+ Deluxe U.S. Sheet Protectors
$11.75/unit
Quantity
Binder EnvelopeBinder Envelope
Note 5
+ Binder Envelope
$15.00/unit
Quantity
CD Pages CD Pages
Note 6
+ CD Pages
$14.50/unit
Quantity
Binder File Rolling CartBinder File Rolling Cart

+ Binder File Rolling Cart
$550.00/unit
Quantity

Order Summary

Binding System

Advantage Two-Ring

Binders

RegulatoryQuantity
SafetyQuantity
CorrespondenceQuantity
EquipmentQuantity
PersonnelQuantity
Investigational ProductQuantity
Patient RecordsQuantity

Tabs
NumericQuantity
MonthlyQuantity
Blank Write OnQuantity

Accessories
40 Page Two-Hole PunchQuantity
40 Page 3-Hole PunchQuantity
DocuCopy Pre-Drilled Paper 20 lb. Quantity
Deluxe U.S. Sheet ProtectorsQuantity
Binder EnvelopeQuantity
CD Pages Quantity
Binder File Rolling CartQuantity

* Upon placing your order, you will receive a Word document template to use as a Table of Contents