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General Information - Step 1 of 16

Company Address/Contacts

Legal Company Name

Comment (If any)

Company Headquarter's address

Comment (If any)

Company Headquarter's Country

Comment (If any)

Other Offices Location Countries

Comment (If any)

Parent Company Name (If Applicable)

Comment (If any)

Type of the company

Comment (If any)

What is the legal form of the Company?

Comment (If any)

Please select the therapeutic area(s) in which you have a significant expertise

Comment (If any)

Owners/Partners names and contact details

Comment (If any)

Headquarters Mailing Address Please specify if it depends on other location

Comment (If any)

Telephone Number (with country code)

Comment (If any)

Fax Number

Comment (If any)

Website / URL

Comment (If any)

Primary Contact Name

Comment (If any)

Primary Contact Position

Comment (If any)

Primary Contact Email

Comment (If any)

Primary Contact Phone

Comment (If any)

Would you like to become a part of ALAMERA, an Empowering Research Alliance dedicated to transforming the scientific landscape through innovative collaboration?

ALAMERA serves as a vibrant hub, bringing together visionaries and innovators from various sectors of the research community. Our members include esteemed CROs, CRUs, PIs, and industry leaders, all contributing their unique expertise to drive groundbreaking research advancements. For more information, please visit the ALAMERA website: https://alamera.net/

Company General Information

Year when company was founded

Comment (If any)

A brief description of the company's history, activities and services

Comment (If any)

Services Provided: Check all that applies; and specify others (if any)

Project management
Site Monitoring
Site selection
Country Feasibility
Safety monitoring
Data management
Biostatistics
Pharmacovigilance
Regulatory services
Site and study Logistic Management Services
Medical writing
Patient Support Programs
Market Research
Market Survey
GxP Auditing and Staffing
Medical Device
Home Nursing
Other, please specify

Comment (If any)

Expertise and Experience in requested service

Comments (if any)

Countries of coverage please list them all (through your own team)

Comments (if any)

If working in partnership please provide countries

Comments (if any)

Staff turnover rate (in the last 2 years)

More than 30%
21-30%
5-20%
Less than 5%

Comments (if any)

Total number of full time employee

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What is the number of outsourced staff in your company?

Comments (if any)

Are job descriptions available, signed and dated for all employees? ( outsourced and your full time employees)

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Are the CVs documented, signed, updated, available for all employees? (including the outsourced ones)?

Comments (if any)

Do you have a process for keeping CVs, job descriptions and roles up to date and consistent with organization charts?

Comments (if any)

Do you conduct performance appraisals regulary?

Please provide SOP names/numbers where applicable related to performance appraisal.

Comments (if any)

Have you recently had management changes? Specify

Comments (if any)

Do you have a handover process? And What is its related form code?

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Are training matrices readily available for all job positions related to the services provided?

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Are training records maintained for each individual involved in providing services?

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Are complete training records readily retrievable for all employees?

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How does your staff access SOPs?

Comments (if any)

Do you perform continuous trainings to your staff?

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What is the percentage of permanent employees to temporary employees?

25% permanent 75 %temp
50% permanent 50 %temp
75% permanent 25%temp
90% permanent 10 %temp

Comments (if any)

Do you have remote-based staff?

Comments (if any)

What Regulations or standards are your personnel trained against? Or work within?

GVP Modules (All current)
ICH GCP
GMP (IMP)
GMP Marketed Product
GSDP
GMP (Cosmetics) ISO 22716
Medical Devices Directive 93/42/EEC
ISO 9001-2015
GDPR
Other

Comments (if any)

Does your company have a minimum training curriculum which is role-based, clearly defined, periodically reviewed, and includes relevant GxP elements?

Comments (if any)

Are staff trained on emergency procedures (e.g. Business Continuity, Disaster Recovery, fire suppression, evacuation) where applicable?

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Do you have a Code of Ethics and Business Conduct? please provide name and code if applicable

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Are staff trained on the Code of Ethics and Business Conduct?

Comments (if any)

Is there a dedicated Quality Assurance (QA) department?

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Does the company have a Quality Policy?

Comments (if any)

Are you quality Certified from any external party?* Please provide more information including accreditation body and validity date

Comments (if any)

Have you undergone any recent (local, international, or regional) inspections from regulating bodies?

Comments (if any)

Do you conduct internal audits ?

Comments (if any)

Does the company work according to asset of standard operating procedures (SOPs)?

Comments (if any)

How often are your SOPs reviewed?

Not specified
Once every 4 or more years
Once every 3 years
Once every 2 years or less

Comments (if any)

Are the procedures in use compliant with EU, FDA and/or other regulatory requirements and guidelines (where applicable)?

Comments (if any)

Do you have a procedure for monitoring and management of quality and performance metrics? Please share the name and code

Comments (if any)

Do you have a procedure for dealing with customer complaints? Please share name and code

Comments (if any)

Do you have a procedure for CAPA management? Please share the name and code

Comments (if any)

Do you have a procedure for external audits/inspections by sponsor, customer, or any health authorities? Please share the name and code

Comments (if any)

How many external audits have you received in last 3 years?

5
7
10
More than 15

Comments (if any)

Do you have a procedure for internal audits management? Please share the name and code

Comments (if any)

Do you have a procedure for documents control and storage?

Comments (if any)

What is the retention period for documentation and electronic records held in archived storage, and what happens at the end of this time period?

One year
More than 5 year
More than 10 year
More than 15 year

Comments (if any)

Do you have an archive facility?

Comments (if any)

Is access restricted to the archiving area?

Comments (if any)

Is there a procedure in place that defines the process for the handling of Personal Information?

Comments (if any)

Does the company maintain essential documents

Comments (if any)

Are the documents kept in a secure location with limited access?

Comments (if any)

What is the procedure for storing these documents during the study and what is the procedure for retaining documents after study closure?

Comments (if any)

Please list what essential documents are kept during the study and what documents are retained by the company after study closure

Comments (if any)

Do you have any archive facility within your premises?

Comments (if any)

What measures do you have in place to restrict access to confidential documents?

Comments (if any)

How is access restricted to the archiving area?

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Are archived files stored in fire proofed areas or cabinets?

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Are archived files located off the floor to avoid water damage?

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How are archived files tracked?

Electronically
Paper
Other

Comments (if any)

Is there a procedure for signing-out archived documents to a client?

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Is there a procedure for returning archived documents from the client to the vendor?

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Do you use off-site storage for archived files?

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If you do use an off-site storage facility, how long are archived files retained at your primary location?

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Can archived records be reliably and efficiently retrieved?

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Do you conduct periodic reconciliations of electronic to physical records?

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How do you document that the reconciliation was conducted and the outcome?

Comments (if any)

Do you contact the client prior to records destruction?

Comments (if any)

Do you have a procedure on records retention?

Comments (if any)

What is the retention period for documentation and electronic records held in archived storage, and what happens at the end of this time period?

One year
More than 5 year
More than 10 year
More than 15 year

Comments (if any)

In what format are records maintained?

Comments (if any)

Do you have a policy or procedure on client confidentiality?

Comments (if any)

Do written agreements regarding data protection exist between your company and your clients?

Comments (if any)

Who is responsible for ensuring compliance to data protection laws?

Comments (if any)

Is there a procedure in place that defines the process for the handling Personal Information?

Comments (if any)

Do you have a documented Business Continuity Plan (BCP) in place to ensure continuity of service in the event of destruction or shut down of the facility?Please share the code and name of the procedure.

Comments (if any)

Is the data/system at rest secured approproiately with respect to its classification?

Comments (if any)

Is this data validated? If yes, how frequently and when was the last time?

Comments (if any)

Is this system compatible with 21CFR Part 11?

Comments (if any)

What technical and organization security measures are used for protecting the information?

Comments (if any)

Do you have a procedure for Data Back-Up?

Comments (if any)

Is there an SOP describing working with the information system/database (validation plan, service, safety, data modification, and data saving)?

Comments (if any)

Do you have a process for password and account management (e.g. frequency of change, rules for set-up, granting and revoking process etc.)?

Comments (if any)

Do you have a process for change control/change management for computerized systems?

Comments (if any)

Please describe your computerized system validation processes, including standard system development lifecycle and validation master plan.

Comments (if any)

Does a physical and logical security plan exist?

Comments (if any)

Do written agreements regarding data protection exist between your company and your clients?

Comments (if any)

Who is responsible for ensuring compliance to data protection laws?

Comments (if any)

Is there a procedure in place that defines the process for the handling Personal Information?

Comments (if any)

Name of Person responsible for Data Privacy

Comments (if any)

Telephone number of Person responsible for Data Privacy

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Email address of Person responsible for Data Privacy

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Do you process personal data as defined under the General Data Protection Regulations (GDPR) on behalf of ClinGroup (and/or ClinGroup's sponsors in specific circumstances) outside of the EEA?

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Do you confirm that they shall only process personal data on documented instructions from ClinGroup?

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Do you confirm that you will only retain personal data in compliance with applicable legislation and contractual obligations?

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Do you have appropriate technical and organisational measures (TOMS) to ensure the security of personal data held by it?

Comments (if any)

Do you confirm that you should ensure sufficient checks are carried out before choosing a sub-contractor/sub-processor in order to evaluate that appropriate privacy and security measures will be applied to the Personal Data they handle on ClinGroup's behalf?

Comments (if any)

Do you confirm that ClinGroup has given its approval to each vendor-designated subcontractor and subprocessor involved in the handling of ClinGroup customers' personal data?

Comments (if any)

What guidelines do you have for controlling staff access on your site?

Card Reader
Key pad
Controlled fingerprint access to all employees
Other
None

"Other" specify

Comments (if any)

What standards do you have for limiting guest access?

Sign-in/Sign-out
Wear Visitor Badge
Other
None

"Other" specify

Comments (if any)

Are there fire extinguishers or a fire suppression system?

Comments (if any)

Is there a power backup generator?

Comments (if any)

Do you conduct pest control?

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Will your company subcontract any services related to ClinGroup clinical studies?

Comments (if any)

Which insurance does your business maintain for its subcontractors? Please explain.

Comments (if any)

Which of the following services does your business outsource?

Comments (if any)

Please provide a list of services which may be subcontracted by the company

Comments (if any)

What is the SOP related to selection and monitoring of subcontractors? Please specify its name and code

Comments (if any)

What is the SOP related to escalating issue related to subcontractors? Please specify its name and code

Comments (if any)

Please provide for the income for the last three years

Comments (if any)

What is the SOP related to Project Management? Please provide its name and code and its table of contents

Comments (if any)

How is information on products and clients projects accessed out of hours?

Comments (if any)

What is the communication channel between project managers and key stakeholders?

Comments (if any)

What is the average number of studies that are assigned to each project manager?

More than 7 studies
More than 5-7 studies
3-5 studies
1 - 3 studies

Comments (if any)

Organization chart if yes, please provide a copy of your company organizational structure

Comments (if any)

Attach a copy of official Registration/Incorporation document(which clearly displays registered address, incorporation date, registration number)

Comments (if any)

Standard Operating Procedures Index

Comments (if any)

Floor plan

Comments (if any)

Please attach a copy of your relevant certfications and/or ISO Certificate

Comments (if any)

Insurance certificate

Comments (if any)

Please provide a copy of your Company Profile

Comments (if any)

Please upload a copy of your SOP Table of Contents for Project Management Services.

Comments (if any)

❖ List of References (Pharma Companies / CROs / Biotechs / Hospitals / Warehouses / Etc.)

* (insert as much rows as needed)

❖ List of References (Pharma Companies / CROs / Biotechs / Hospitals / Warehouses / Etc.) * (insert as much rows as needed)

Institution Name

Contact person

Contact details

Time needed in advance for Project request * (of days)

Expected rate per service ?

Layout

Country

Price USD

Service

Date

Source

Type

Company Address/Contacts

Company General Information

Expected rate per service ?

arabmed-CRO is the regional full-service Contract Research Organization

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