Due Diligence Questionnaire

Due – Diligence Questionnaire
Company Name:
Company Address:
Company Representative:
Telephone #:
Date of the Assessment:
How many employees does the company
have?
List the products / services of the
company:
How long has the company been in

business?
Is the company ISO Certified?
Has the company ever been through a

regulatory inspection? (by whom, when,
results?)
Persons interviewed:
Form Created: 30-Dec-2009 Confidential Page 1 of 33

EXECUTIVE SUMMARY
Summary of Key Findings:

1.
Other observations:
1.

TABLE OF CONTENTS
1.0 GENERAL / CORPORATE .................................................................................................. 4
2.0 QUALITY ASSURANCE ..................................................................................................... 6
3.0 PROJECT MANAGEMENT ............................................................................................... 10
4.0 CLINICAL MONITORING ................................................................................................ 13
5.0 MEDICAL MONITORING AND SAFETY ....................................................................... 14
6.0 DATA MANAGEMENT..................................................................................................... 16
7.0 DATA CAPTURE SYSTEMS (EDC, IVR/IWR, ePRO) ................................................... 21
8.0 BIOSTATISTICS ................................................................................................................ 22
9.0 RESOURCE MANAGEMENT & PROCESS IMPROVEMENT ...................................... 24
10.0 INFRASTRUCTURE AND SUPPORT ............................................................................ 25
11.0 REGULATORY REQUIREMENTS (21 CFR Part 11) .................................................... 28
12.0 ADDITIONAL AREA(S) REVIEWED (please indicate) ................................................. 32
13.0 Supporting Evidence .......................................................................................................... 33

GENERAL / CORPORATE
1.0 GENERAL / CORPORATE

Ref. No. Requirements Observations Is there a finding Recommendation for
requiring corrective corrective action
action? If yes, explain.
1.1 Is there an organizational chart available? YES NO
* Does it show the interrelations between
departments?
* How many employees are employed world wide?
* What % of employees are full time versus
contracted outside personnel or consultants
1.2 What is the corporate financial profile? YES NO

* Annual revenues?
1.3 Does the company have world wide YES NO

experience?
1.4 What is the average management turnover rate YES NO
for the past 12-24 month period?
1.5 Does the company have personnel dedicated to YES NO
Ophthalmology trials which include surgical
(device), Ophthalmology Pharmaceutical and
consumer products?
1.6 Has the company ever been audited by the US YES NO

FDA or other regulatory agency?
* Obtain copies of results if you can
1.7 In what Therapeutic areas does the company YES NO

have experience?
* List or obtain evidence (graph?)
1.8 What % of your studies are in each phase of YES NO

clinical development (Phase I – IV)?
* Seek supporting documented evidence –
graphical is OK.
Form Created: 23-Feb-2010 Confidential Page 4 of 33

GENERAL / CORPORATE

1.9 Does the company have job descriptions for YES NO
each employee?
* Does it include current responsibilities?
Signature? Training requirements?
1.10 Is there a formal training program for all YES NO
employees?
* Does it include SOPs? Job skills? Outside
training? Regulatory training like GCP, 21 CFR
Part 11 and etc.?
1.11 Who is responsible for ensuring employees are YES NO

properly trained and have the appropriate
experience to fulfill their role?
1.12 What % of the company’s trials use their own YES NO
SOPs versus client SOPs?
1.13 Is there a formal record retention policy? YES NO

QUALITY ASSURANCE
2.0 QUALITY ASSURANCE

2.1 Is a formal Quality Assurance Procedure/Plan YES NO
or Manual available?
If yes, is it effectively implemented?
If no, does the company have a published
statement or standard for quality?
* Are written procedures, which establish the
Quality System developed, implemented and
maintained?
* Is there an available Quality Policy statement
and does it reflect top management's philosophy,
goals and commitment to quality?
2.2 Is there a documented Quality System? YES NO

* Does it show the interrelations between
departments?
2.3 Are quality responsibilities clearly defined and YES NO

supported?
Where?
* Are there policies, procedures, SOPs, and/or
requirements that define who are responsible for
the effective implementation of the Quality
System?
* Are resources sufficient?

QUALITY ASSURANCE

2.4 Is there evidence of management's YES NO
commitment to continuous quality
improvements?
* Are Quality improvement objectives defined
and supported by identifiable means of
achievement and results?
* Evidence can include metrics, reduction of
deficiencies by training, and corrective &
preventive action improvements.
2.5 Is there a process for control of YES NO

Documentation?
For SOPs?
For projects documents?
For supporting User Documentation?
* Seek evidence that the process is implemented,
understood and providing the desired results.
2.6 Does the documentation process include: YES NO
Formal Review and Approval?
* Electronic Approval?
* Traditional wet signature approval?
{indicate the type of approval process}
* Revision Control?
* Revision History?
2.7 Is there a cyclic review to ensure the YES NO

documents are still applicable?
Are SOPS within the review cycle? How many
and which ones are outside the review cycle?

QUALITY ASSURANCE

2.8 Is the company utilizing an audit program to YES NO
verify the performance of their quality system?
* Does this program demonstrate the
effectiveness of internal audits through:
-- Records
-- Corrective actions
2.9 Are CAPA metrics maintained? YES NO

Number of Open, Closed, time to closure?
2.10 Are audits planned, scheduled and conducted YES NO
by trained personnel independent from the
areas being audited?
* Seek supporting documented evidence.
2.11 Do the persons responsible for the respective YES NO
area/function review the results of audits?
* Seek supporting documented evidence of review
2.12 Are the results of audits reported to YES NO
management?
* Seek supporting documented evidence of review
2.13 Is there evidence that management takes the YES NO
proper steps to resolve issues identified in an
audit (by internal or external sources)?
2.14 Is there a process for preventing and/or YES NO

correcting product/process problems?
* Documented process
* Tracking of corrective action, (follow-through)
* Training

QUALITY ASSURANCE

2.15 Is there a process in-place for the control of YES NO
their vendors/Companys?
* Vendor rating or measurement system.
* Vendor assessments.
* Approved Vendor Listing.
2.16 Do Quality Records identify the capability and YES NO

performance of the Development Process and
the Quality System?
* Are records being kept for all areas that have
been identified as requiring records?
2.17 Are Quality Records YES NO

Identified,
Collected,
Indexed,
Accessible,
Filed,
Stored,
Disposition,
To prevent loss or damage?
* Are records legible and easily obtainable?
2.18 Are statistical techniques used to monitor YES NO

trends and verify corrective action and
continuous improvement?
* Look for evidence that statistical techniques are
adequate for the process.
2.19 Does your Clinical QA organization have YES NO

experience with Ophthalmology?
2.20 Does your Clinical QA organization have YES NO
experience with clinical auditing?

PROJECT MANAGEMENT
3.0 PROJECT MANAGEMENT

3.1 Does the Clinical Project Management (CPM) YES NO
team have sufficient experience in the
following:
 Ophthalmology
 Surgical/IOL
 ENT
3.2 Describe company’s project organization YES NO

structure.
3.3 What is the typical number of projects YES NO

managed by each CPM at a given time? (start
up versus maintenance).
3.4 What is the company’s CPM turnover rate in YES NO

the past 24 months?
3.5 What is the percentage of studies that started YES NO

and ended with the same project manager?
3.6 Is there a documented Project Management YES NO

process?
*Overview?
3.7 Is there a defined project management YES NO

transfer or handoff process documented?
3.8 Does the company have experience planning YES NO

and running Investigator Meetings?
3.9 How many Investigator meetings has company YES NO

been involved with in the past 2 years?

PROJECT MANAGEMENT

3.10 Does company have experience planning and YES NO
running both live and virtual Investigator
meetings?
*How virtual meetings are conducted?
3.11 Who typically delivers training to the PI? YES NO

(PM, training organization, outside source).
*Please explain.
3.12 Does the company have medical writing YES NO

experience? Please explain.
3.13 Does the company have CPM capability YES NO

world-wide? Please describe how project
management is handled around the world.
3.14 Does the company have experience managing YES NO

supplies both locally and globally?
* drug supply, device supply
3.15 How do they ensure available drug and device YES NO
globally?
3.16 Please describe any tools used for subject YES NO

recruitment.
3.17 How does company ensure subject retention? YES NO
3.18 Does company maintain an investigator YES NO

database?
*Responsibilities? Updates? See below…

3.19 How often is the investigator database YES NO
updated? Who has access to update it?

PROJECT MANAGEMENT

3.20 Do investigator records indicate experience YES NO
with ophthalmology studies? Previous
Sponsor trials?
3.21 What is company’s method for developing YES NO

relationships with principal investigators?
3.22 What % of company’s principal investigators YES NO

do repeat work with their organization?
3.23 What typical metrics and or reports are YES NO

presented to sponsor personnel for project
progress and review?
(e.g. performance against budget, DCR’s, etc.).

* are example reports available for review?
* Are reports & metrics spelled out in the project
plan (or contract)

CLINICAL MONITORING
4.0 CLINICAL MONITORING

4.1 Does the Monitoring team have experience in YES NO
the following:
 Ophthalmology
 Surgical/IOL
 ENT
 Other?
4.2 What is the Monitoring personnel turnover YES NO
rate in the past 24 months?
4.3 Does company world-wide monitoring YES NO

capabilities? Please describe.
4.4 Are monitors trained in the query process for YES NO

the study?
4.5 How is the trial master file (TMF) YES NO

maintained? If electronic, how is access
controlled?
4.6 Does company have a Rapid Startup Group? YES NO

Please describe tasks that are typically
included.
4.7 What is the average time frame from protocol YES NO

approval to site initiation?
4.8 What metrics are typically provided to the YES NO

sponsor to oversee monitoring activities and
progress?

MEDICAL MONITORING AND SAFETY
5.0 MEDICAL MONITORING AND SAFETY

Ref. No. Requirements Observations Is there a Recommendation for
finding corrective action
requiring
corrective
action? If
yes, explain.
5.1 Does company provide medical monitoring YES
services?
NO
5.2 What experience does company have with YES

international safety reporting?
NO
5.3 Do the safety personnel have experience with YES

 Safety signals NO
 SAE narratives
 Safety Monitoring Boards
5.4 Please describe the typical SAE reconciliation YES

process. NO
5.5 Does company have experience with the YES

following safety systems (Relsys, ClinTRACE,
Argus… OTHER.)? NO
*Does company allow the sponsor to specify the

system used?
5.6 Is there a documented process for unmasking? YES

Please describe scenarios where this would be
invoked. NO
5.7 Does company perform SAE Coding? YES

What dictionaries do you use or have
experience with? NO

MEDICAL MONITORING AND SAFETY
Ref. No. Requirements Observations Is there a Recommendation for

finding corrective action
requiring
corrective
action? If
yes, explain.
5.8 YES
Does company have responsibility for any site
interaction? Please explain. NO
5.9 Does company handle expedited reporting? YES

NO

DATA MANAGEMENT
6.0 DATA MANAGEMENT

6.1 Does the Data Management team have YES NO
experience in the following:
 Ophthalmology
 Surgical/IOL
 ENT
 Other?
6.2 What is the DM staff turnover rate in the past YES NO
24 months?
6.3 Does the DM personnel have experience YES NO

working with both paper and/or EDC
systems?
(Please specify which EDC systems you have
experience with)
6.4 Is there a documented procedure for CRF YES NO

design?
* Review with any supporting procedures
* Does it cover design, development, version
control?
* Can the company describe the “life of a CRF”
at their company?
* Is the CRF designed along with the protocol to
ensure collection of ONLY data specified in the
protocol?
* Are CRF’s designed with primary safety and
efficacy endpoints in mind as the main goal of
data collection?

DATA MANAGEMENT

6.5 Is there formal CRF training at clinical sites YES NO
prior to subject enrollment?
* Documentation of trainings? Storage?
6.6 Is there a library of standard forms? YES NO

*Storage? Access? Maintenance?
6.7 Does the DM group use NCR paper or other YES NO

means to ensure exact replicas of paper
collection tools?
6.8 How is data entered from CRF’s? YES NO

* Explain process, any specific requirements?
6.9 Are Data Clarification Forms (DCF) YES NO

used?
* Provide example
6.10 What data cleansing procedure are used? YES NO

* Study specific or SOP?.
6.11 How is access to clinical data controlled? Can YES NO

you explain who has access to clinical
databases and at what point during a study?
6.12 Database Design? YES NO
* Is it COTS1 or designed in house?
* Does it include meta data components as part
of data schema?
1
Commercial Off The Shelf Software (COTS)

DATA MANAGEMENT

6.13 Documentation Storage? YES NO
* Orignal CRF’s?
*DCRs, other documentation?
6.14 Is there adequate Source Control YES NO

(Configuration Management) for software
databases?
* When does control start?
6.15 Does the Source Control contain the following: YES NO

Access Control?
* Is the source code protected from unauthorized
changes? After database lock?
Version Control?
* Explain this process.
Identification Control?
* Labeling.
6.16 Are there documented procedures for each YES NO

data management process?
* Are written procedures controlled and
approved?.
* Do the procedures identify the responsibility and
authority for implementation?
* Are the procedures accessible to the persons
performing the tasks?
6.17 How is clinical data shared and or transferred? YES NO

*With other vendors?
*Is removeable media encrypted or password
protected?
* During the study?
* At Study completion?

DATA MANAGEMENT

6.18 Does the company identify and control YES NO
nonconforming product (software bugs)?
* Describe the process used by the company?
6.19 Is there a flow chart or process that defines YES NO

how product or CRF changes are made?
* Does the team have the authority to make
accept/reject decisions?
6.20 How are changes to clinical databases or YES NO
systems controlled?
* Describe this process.
* How are customers notified of these changes?
6.21 Is the database environment backed-up? YES NO

Is the data/source code stored off-site?
* Seek evidence of the process.
* Are there records to support this process?
6.22 What is the query management process? YES NO

* Flowchart?
6.23 Does the company ensure that electronic data YES NO

capture systems do not restrict the answers that
site personnel can provide in a way that
introduces bias into the study?
* Describe process?
6.24 Is there a documented Disaster Recovery YES NO

Program in place for the database
environment?
* Has it be it been tested?

DATA MANAGEMENT

6.25 Is there a Data Management Plan, SOP or YES NO
Template (if study not active).
6.26 Does company ensure that data can be traced YES NO

from acquisition to report and analysis?
6.27 Does company ensure that systems have easily YES NO

accessible audit trails for data audit and
investigation?
6.28 Describe the data archiving procedure? YES NO

*Is this documented?

DATA CAPTURE SYSTEMS (EDC, IVR/IWR, ePRO)
7.0 DATA CAPTURE SYSTEMS (EDC, IVR/IWR, ePRO)

7.1 Does the company have dedicated EDC YES NO
resources (personnel)?
7.2 Does the company have dedicated IVR/IWR YES NO

7.3 Does the company have dedicated ePRO YES NO

7.4 Please list the EDC systems with which you YES NO
have worked?
7.5 Please indicate which ePRO systems you have YES NO

worked with (InVivo, PHT, CRF, etc.)?
7.6 How does company ensure data capture YES NO

systems are compliant with 21 CFR Part 11
and consistent with CSUICI?
7.7 Does company have documented development YES NO
life cycles for all data capture tools?
7.8 Are data capture tools validated prior to YES NO

deployment in production?
7.9 Does company facilitate User Acceptance YES NO

testing prior to implementation and
deployment to site?
*How is this documented?
7.10 Does company train sites in the use of data YES NO

capture tools?
*How is this typically accomplished?

BIOSTATISTICS
8.0 BIOSTATISTICS
8.1 Describe the typical profile of the biostat YES NO
team? (e.g. Number of staff? Do they all have
statistical degrees? Average number of years
of biostat experience, etc.)
8.2 What is the turnover rate among YES NO

biostatisticians in the past 24 months?
8.3 Describe your typical business model(s) in YES NO

respect to the biostatistics services you provide
(e.g., traditional CRO model, staff
augmentation, etc.). Would you consider one
of more of these models to be a focus?
8.4 Describe the range of biostatistics services that YES NO
you offer (e.g., study design, protocol
development, analysis plan development, etc.).
8.5 Comment on your in-house biostatistics YES NO

expertise to support protocol/SAP
development in Bayesian statistics, interim
analyses, other advanced design methods, etc.
8.6 Do you have in-house expertise in modeling YES NO

and simulation?
8.7 Specific to staff augmentation, if applicable for YES NO

your organization, what metrics can you
provide to document timeliness for identifying
qualified, biostatistics and programming
candidates for Sponsors?
8.8 Describe the profile of your statistical YES NO

programming organization (e.g., number of
staff, years experience, etc.).

BIOSTATISTICS

8.9 What statistical programming languages do YES NO
you support with in-house expertise? SAS?
Other?
8.10 Describe your quality processes for statistical YES NO

programming, including validation
procedures, traceability, audit trails, etc.
8.11 Do you have technology solutions in place such YES NO

as a clinical data repository or statistical
computing environment? Describe.
8.12 What are your policy restrictions, if any, in YES NO

respect to providing SAS code, .log, and .lis
files to Sponsors as an end-of-contract
deliverable?
8.13 Is there a documented process for unmasking YES NO

treatment codes prior to database lock?
Please describe scenarios where this would be
invoked.
8.14 What is your target timeline for distribution of YES NO

initial study results to Sponsors following
database lock? What about complete TLGs?

RESOURCE MANAGEMENT & PROCESS IMPROVEMENT
9.0 RESOURCE MANAGEMENT & PROCESS IMPROVEMENT

9.1 Will company be able to provide unit based YES NO
pricing?
9.2 Is the company willing to provide pricing YES NO

based on Sponsor units and/or requirements?
9.3 Does company have any experience with YES NO

reward/penalty clauses? Please describe.
9.4 What is the average number of change YES NO

orders/project?
9.5 What typical project metrics are provided to YES NO

measure progress?
9.6 Are financial metrics available to monitor YES NO

progress against budget?
*Please detail.
9.7 Is company willing to begin studies under a YES NO

signed Letter of Intent or require a full
contract before work can begin?

INFRASTRUCTURE AND SUPPORT
10.0 INFRASTRUCTURE AND SUPPORT

10.1 Is access to the facilities controlled? YES NO
* Explain?
*Office
* Data Center
* Are unauthorized attempts detectable?
* What action would be taken?
10.2 Is the computing environment protected: YES NO

From unauthorized access?
* Firewall?
 * Periodic auditing of access logs to
detect unauthorized attempts?
Unauthorized changes?
* Review the procedures supporting this process.
* Decommissioned users?
10.3 Is access to the computer system (both YES NO

physical and logical) controlled?
Access limited to authorized individuals?
Are failed attempts tracked?
10.4 Do change control procedure exist for YES NO
hardware changes?
* Are all hardware changes recorded?
* Controlled
* What type of testing (validation) is done when
changes are made to the computer systems? Is it
recorded?
10.5 Is there maintenance program in place for YES NO

computer systems?


* The extent of the program should be
concurrent with the complexity and sensitivity of
the equipment.
* Can the company demonstrate that P/M is
performed on a scheduled periodic basis where
appropriate?
* Does the company maintain records of P/M?
10.6 Is there a documented process for the back- YES NO

up and off-site store of electronic records and
critical computer programs?
* Seek evidence of the process.
* Are there records to support this process?
10.7 Is there a documented Disaster Recovery YES NO

Program (DRP) in place for the computer
environment?
* Has it be it been tested?
* Is testing of the disaster recovery process
schedule to be accomplished on a periodic basis?
10.8 Is there a documented business continuity plan YES NO
that goes hand in hand with the DRP above?
10.9 Does company have a live support center YES NO

available 24/7/365, 24x5 or business hours??
10.10 What systems are supported by the internal YES NO

support center?
10.11 Is the support center ever outsourced? YES NO
10.12 Please describe the overall support center? Is YES NO

it in one location? Does it follow the sun in


terms of local office support? What is the
primary and secondary language support?
10.13 Does company provide local or toll free YES NO

telephone access on a world wide basis to the
support center?
10.14 Does the support center provide support via YES NO

telephone? Fax? Email? Live chat? Other?
Please describe methods.
10.15 What is company’s typical support center YES NO

volume in terms of cases/month?
10.16 What is the typical close time for support YES NO

center cases? What is the % of cases closed on
first contact?

REGULATORY REQUIREMENTS (21 CFR Part 11)
11.0 REGULATORY REQUIREMENTS (21 CFR Part 11)

11.1 Identify applicable regulations that the List:
company is required to meet.
11.2 Does the company understand the YES NO

requirements of 21 CFR Part 11?
* Seek evidence of this.
* Training Records should contain documented
evidence to support this.
11.3 Does the company have a 21 CFR Part 11 YES NO

policy statement?
* If so, review.
11.4 Is the product validated prior to release to YES NO

production or to clients?
* Internal and external release.
11.5 Are Part 11 requirements clearly identified in YES NO

the:
Product Requirements?
Development Specifications?
Test Specifications or test cases?
* Is there a document that traces the product
requirements  the specifications  the
regulation?
11.6 Can the system discern invalid or altered YES NO

records?
* Explain.
* Is there evidence that this has been tested?
11.7 Is the audit trail protected from unauthorized YES NO
changes?


11.8 Does the audit trail capture all actions that YES NO
create, modify, and/or delete data from
electronic records?
11.9 Do all actions in the audit trail contain a date YES NO

time stamp?
Operator entries?
Reason for changes?
11.10 Do changes to electronic records obscure YES NO

previously recorded information?
11.11 Is the audit trail available for viewing? YES NO

Printing?
11.12 Is the audit trail linked to the data? YES NO
* Explain this for the product being audited?
11.13 Security -- Is system limited to authorized YES NO

individuals?
* Document the type of access controls that are
available to the software.
11.14 Are operational checks implemented as YES NO

appropriate?
Where required, does the system permit
forced actions (i.e. actions in a particular
order)?
11.15 Is the system used as an “open” or “closed” YES NO
system?


* Explain.
11.16 Do signed electronic records contain the YES NO
printed name of the signer?
Date time stamp when the signature was
executed?
The meaning of the signature?
* Such as review, approval, responsibility, or
authorship?
11.17 Are the electronic signatures linked to the YES NO
electronic record?
11.18 Are the electronic signatures unique to one YES NO

individual?
11.19 Has the organization certified to the agency YES NO

that electronic signatures used on after August
20, 1997, are intended to be the legally binding
equivalent of traditional handwritten
signatures?
11.20 Are electronic signature based on two distinct YES NO
identification components?
*Such as identification code and password?
Are both components required for the initial
execution of the electronic signature?
11.21 Do controls exist that ensure the security and YES NO

integrity of the electronic signature?


11.22 Do controls exist that ensure the uniqueness of YES NO
each combination of identification code and
password?
11.23 Do safeguards exist to prevent the YES NO

unauthorized use of passwords and
identification codes?
Detection?
Reporting?

ADDITIONAL AREA(S) REVIEWED (please indicate)
12.0 ADDITIONAL AREA(S) REVIEWED (please indicate)

12.1 YES NO
12.2 YES NO

Supporting Evidence
13.0 SUPPORTING EVIDENCE

List Document(s) that have been reviewed Is there a finding requiring corrective Recommendation for corrective action
action that has not already been noted?
If yes, explain.

Due Diligence Questionnaire

Загружено:

Сведения о документе

Исходное описание:

Оригинальное название

Авторское право

Доступные форматы

Поделиться этим документом

Поделиться или встроить документ

Параметры публикации

Этот документ был вам полезен?

Это неприемлемый материал?

Авторское право:

Доступные форматы

Due Diligence Questionnaire

Загружено:

Авторское право:

Доступные форматы

Due – Diligence Questionnaire

How long has the company been in

Is the company ISO Certified?

Has the company ever been through a

Form Created: 30-Dec-2009 Confidential Page 1 of 33

Summary of Key Findings:

Form Created: 30-Dec-2009 Confidential Page 2 of 33

1.0 GENERAL / CORPORATE .................................................................................................. 4

2.0 QUALITY ASSURANCE ..................................................................................................... 6

3.0 PROJECT MANAGEMENT ............................................................................................... 10

4.0 CLINICAL MONITORING ................................................................................................ 13

5.0 MEDICAL MONITORING AND SAFETY ....................................................................... 14

6.0 DATA MANAGEMENT..................................................................................................... 16

7.0 DATA CAPTURE SYSTEMS (EDC, IVR/IWR, ePRO) ................................................... 21

8.0 BIOSTATISTICS ................................................................................................................ 22

9.0 RESOURCE MANAGEMENT & PROCESS IMPROVEMENT ...................................... 24

10.0 INFRASTRUCTURE AND SUPPORT ............................................................................ 25

11.0 REGULATORY REQUIREMENTS (21 CFR Part 11) .................................................... 28

12.0 ADDITIONAL AREA(S) REVIEWED (please indicate) ................................................. 32

13.0 Supporting Evidence .......................................................................................................... 33

Form Created: 30-Dec-2009 Confidential Page 3 of 33

1.0 GENERAL / CORPORATE

1.2 What is the corporate financial profile? YES NO

1.3 Does the company have world wide YES NO

1.6 Has the company ever been audited by the US YES NO

1.7 In what Therapeutic areas does the company YES NO

1.8 What % of your studies are in each phase of YES NO

Form Created: 23-Feb-2010 Confidential Page 4 of 33

Ref. No. Requirements Observations Is there a finding Recommendation for

1.11 Who is responsible for ensuring employees are YES NO

1.13 Is there a formal record retention policy? YES NO

Form Created: 23-Feb-2010 Confidential Page 5 of 33

2.0 QUALITY ASSURANCE

2.2 Is there a documented Quality System? YES NO

2.3 Are quality responsibilities clearly defined and YES NO

Form Created: 23-Feb-2010 Confidential Page 6 of 33

Ref. No. Requirements Observations Is there a finding Recommendation for

2.5 Is there a process for control of YES NO

2.7 Is there a cyclic review to ensure the YES NO

Form Created: 23-Feb-2010 Confidential Page 7 of 33

Ref. No. Requirements Observations Is there a finding Recommendation for

2.9 Are CAPA metrics maintained? YES NO

2.14 Is there a process for preventing and/or YES NO

Form Created: 23-Feb-2010 Confidential Page 8 of 33

Ref. No. Requirements Observations Is there a finding Recommendation for

2.16 Do Quality Records identify the capability and YES NO

2.17 Are Quality Records YES NO

2.18 Are statistical techniques used to monitor YES NO

2.19 Does your Clinical QA organization have YES NO

Form Created: 23-Feb-2010 Confidential Page 9 of 33

3.0 PROJECT MANAGEMENT

3.2 Describe company’s project organization YES NO

3.3 What is the typical number of projects YES NO

3.4 What is the company’s CPM turnover rate in YES NO

3.5 What is the percentage of studies that started YES NO

3.6 Is there a documented Project Management YES NO

3.7 Is there a defined project management YES NO

3.8 Does the company have experience planning YES NO

3.9 How many Investigator meetings has company YES NO

Form Created: 23-Feb-2010 Confidential Page 10 of 33

Ref. No. Requirements Observations Is there a finding Recommendation for

*How virtual meetings are conducted?