Common Questions about us.

Q: Are you hiring?
A: Currently, we are not hiring full-time employees. However, we are always interested in making new contacts and associates are welcome.

Q: Do your associates have foreign language skills?
A: Many do, including French, Italian, Spanish, Swedish, Chinese, Farsi and Russian.

Q: Do your auditors have the ability to perform Data Management audits?
A: Many of our auditors have extensive experience auditing all aspects of Data Management including; CRF development, database programming, EDC set-up and validation, database outputs including SAS TFLs and more.

Q: What is Rescue Monitoring?
A: We have come to the assistance of several clients facing difficult monitoring chanllenges such as; slow subject enrollment, changing site monitors, need for immediate temperary monitoring support.

Insite Quality Assurance, Inc. was initially founded as cGXP Consultants (a sole proprietorship) in 2000 by Michael Donatelli as a specialized GCP, GLP, GMP consulting and contract audit vendor. Since that time, the company has seen remarkable growth in its business and demand for services, adding Process and Systems Assessments, Computer Validation Audits, Good Tissue Practice Audits, Medical Writing and Rescue Monitoring Services to our portfolio of service offerings.

On March 22, 2010, we officially incorporated as Insite Quality Assurance, Inc. a full service drug, biologics, medical device, nutritional supplements and veterinary quality contract vendor. Why Insite? Because we have the ability to place a qualified professional, on site, anywhere around the world, to fill urgent significant client needs.

Insite Quality Assurance, Inc. professionals provide quality contract services to the bio-pharmaceutical, device, nutritional supplements and veterinary medicines industries specializing in new product development. Insite QA Inc. has proven abilities in the development of Quality Management Systems, GXP regulatory compliance inspections, Rescue Monitoring and medical writing. Our global presence offers our clients a truly unique depth and breadth of experience and the ability to provide efficient services and solutions. We are committed to delivering products and services that ensure quality development outcomes to shorten time to market for new medical therapies.

Insite Quality Assurance Code of Ethics

Approved by Board - 26MAR2010

All employees and associates of Insite Quality Assurance, Inc. shall represent the company and the profession of consulting with integrity and professionalism. Ethics are at the core of the relationship that Insite Quality Assurance, Inc. has with its clients due to the high level of trust that our clients grant us and because of the access that we have to the confidential and proprietary inner workings of our clients. Adherence to this Code is an assurance to our clients that members of Insite Quality Assurance, Inc. maintain the highest standards of professionalism in their conduct with clients, the clients’ customers and stakeholders, and their colleagues. 
All employees and associates of Insite Quality Assurance, Inc. are responsible to uphold this Code of Ethics.

Responsibilities to the Client
We shall always act in the best interest of our client, providing professional services with integrity, objectivity, fairness and independence.
We shall only accept assignments for which the employee or associate has the qualifications, knowledge and skill to serve the client effectively.
Before accepting an assignment we shall reach a mutual understanding with the client as to project objectives, scope, work plan, and costs.
At all times, we shall avoid conflicts of interest or the appearance of conflicts of interest. Employees or associates shall not accept simultaneous assignments from two or more clients who have potentially conflicting interests without informing all parties in advance and securing all parties’ written prior agreement or understanding.
We shall treat our clients’ information as confidential and take all reasonable precautions to prevent access by unauthorized people. We shall not take advantage of such privileged information for use by our employees or associates or another client, without appropriate permission.
We shall not engage in any malfeasance, dangerous behavior, or illegal activities in any matter related to an assignment.

Responsibilities to the Profession of Consulting
We shall not adopt any method of obtaining business that detracts from the professional image of Insite Quality Assurance, Inc. its employees or associates including, but not limited to:

• Deceptive advertising; 
• Misrepresenting qualifications or experience; 
• Denigrating other individual consulting practitioners, consulting firms, or the consulting profession.

Other than submitting a bid in an openly announced competition for consulting services,
We shall not knowingly attempt to secure clients or business from a client that has a prior contractual relationship with an Insite Quality Assurance, Inc. associate.
We shall respect the rights of consulting colleagues and firms and shall not use their proprietary information or methodologies without permission.
We shall promote adherence to the Code of Ethics by Insite Quality Assurance, Inc. employees and associates and other colleagues, whether or not working on the member’s behalf. Perceived violations of the Code of Ethics shall be reported to the Insite Quality Assurance Board of Directors.

Business continuity is critical. Our professional retainer services are essential when immediate professional regulatory compliance advice is an absolute necessity. Our nominal quarterly fee structure gives your organization a strategic advantage. With InSite QA professionals only a phone call away, we are as close as the office next door. Email us for a free quote today.

Developing written processes is not simply writing SOPs. To structure a compliant and efficient development system begins by understanding your company and it's internal customers. To ensure the elimination of redundancies and implementation of process efficiencies, we create process maps that clearly show process, responsibilities and authorized decision makers. Only then can efficient and effective procedures be written.

Our auditors are selected based on their proven abilities, level and depth of experience in each of these areas and match the auditors with our clients needs. A sampling of the types of compliance activities follows:

Systems Audits: Our systems audit approach is to tailor the audit process to your particular needs. Audits are performed to the applicable standards and regulatory requirements.

Good Clinical Practices Audits: Performed according to Title 21 CFR Parts 50, 54, 56, 312, 314, 316, 320, 812, 814, ICH Guidelines E2A, E2C, E3, E6, E9, M4

• Pre-submission document reviews for INDs, Protocols, Consents, CRFs, Investigator Brochures, Final Study Reports, NDAs, BLAs, PMAs and MAAs and computer assisted applications
• CRO pre-and post-selection assessments
• Routine and For Cause Clinical Investigator Site Audits
• Inspection Readiness Assessments
• Clinical Database Audits
• Ethics Committee (IRB) Inspections
• Inspections of Specialized Contract Facilities
• Represent/Assist Corporations with Due Diligence Inspections
• Assist Corporations with FDA and EMEA Inspections
• Compliance Audit Database Development

Clinical and Non-Clinical Laboratory Audits: These audits are performed according to Title 21 CFR Parts 58, Title 42 Part 493, ICH Guidelines S2A, S3B, S4, S6

• QA Unit GLP assessments and audits
• GLP protocol reviews
• Toxicology Laboratory Systems Audits
• PK/PD, ADME laboratory and data evaluations
• Laboratory pre- and post-selection assessments
• Clinical Laboratory test performance investigations

Good Manufacturing Practices Audits: These audits are performed according to Title 21 CFR Parts 210 to 290, 600 to 680, 820 to 822, ICH Guidelines E2B, E2D

• Vendor/supplier qualification inspections
• Manufacturing Facility Inspections
• Manufacturing Process Validation Inspections
• Post Marketing Drug Safety Surveillance Inspections
• Inspections of Specialized Contract Facilities
• Comprehensive batch record review
• CMC documentation audits

Computer Validation: These audits are performed according to Title 21 Part 11, ICH Guidelines E9

• Electronic Data Capture Vendor Audits
• Interactive Voice Recognition Systems (IVRS) audits
• Comprehensive software development life-cycle documentation review

Occassionally, a study sponsor will experience the need for addtional monitoring support for a variety of reasons;

The addtion of new investigative sites to boost slow enrollment,

Replacement of a study monitor,

Supplementing current monitoring activities at a high enrolling site,

Co-monitoring or CRO oversight.

Certainly, there is a host of other scenarios that can affect the need for Rescue Monitoring. When that need arises, Insite Quality Assurance, Inc. contract monitors understand the need for fast, responsive and targeted effort to bring monitoring efforts under control.

Compliance to regulatory requirements is mission critical in the pharmaceutical/biotech industries. Therefore, it is essential to build a sound Quality Management System (QMS) and implement a periodic review of the QMS. Insite QA specializes in Research and Development QMS development from the ground up.

Our clients have found significant improvements in efficiencies after performing GAP Analysis on their current development systems. Insite QA uses the latest in Process Mapping techniques including RACI Diagrams to identify process redundancies and deficiencies to get your company operating efficiently and effectively.

 

The successful approval of your new product application can be severely impacted by the state of your office, personnel, investigators and manufacturing facilities state of Inspection Readiness. We have successfully assisted many of our clients with assuring inspection preparedness. Our Pre-approval preparation efforts focus on:

• New Product Application/Documentation Reviews
• Accuracy and Adequacy of supporting documents and procedures
• Personnel (Sponsor and Investigator) training on inspection process
• Mock inspections

Your human resources are perhaps the most valuable tool in the Research and Development organization and are critical to successful marketing approval. Our training classes are customized to your needs and are based on real experiences and the current state of global regulatory authorities.

 GXP Training and Education Programs

• Train your corporate personnel on Worldwide Regulatory requirements
• Customized training programs suited to corporate development needs
• International GXP training workshops
• Basic GXP Principles
• Advanced topics
  • HIPAA Requirements in Clinical Research
  • Detecting Fraud
  • EMEA Inspections: Process and Current Happenings
  • CRO Inspections
  • Due Diligence Inspections
  • SAE Reporting Requirements
  • Data Trending

Insite QA staff and associates have a broad depth of experiences in the development of new drugs, biologics, medical devices, diagnostics and gene therapies in a wide array of therapeutic areas.

Oncology	Hematology	Infectious Diseases	Neuroscience
Cardiovascular	Urology	Respiratory	Dermatology
Endocrinology	Gastroenterology	Immunology	Ophthalmics

 

Our professional associates have a wealth of skills in the pharmaceutical and biotech industries that only years of experience can provide. A summary of our associates experiences is provided below.

InSite QA	Industry Experience	GCP	GLP	GMP	Medical Writing	Computer Validation
Average Years of Experience	26	18	17	20	24	14
Most Experience (Years)	35	30	29	33	24	16
Least Experience (Years)	12	6	3	5	23	10

Members of the InSite QA team have contributed to the successful approvals of the following products:

• ICON® Strep-B Diagnostic Test(TM) (Streptococcus b, 1993)
• ICON II® HCG Test(TM) (Pregnancy, 1993)
• Zocor® (Cholesterol lowering agent, NOV1997)
• Fosamax® (Osteoporosis, 29SEP1995)
• Proscar® (Benign Prostatic Hyperplasia, 1992)
• Proleukin® (Renal Cell Carcinoma, Melanoma, JAN1998)
• Betaseron® (Multiple Sclerosis, 17MAY1996)
• Tricelluvax® (Diphtheria, Tetanus and Acellular Pertussis, EU 1999)
• Tobi® (Cystic Fibrosis, 21NOV1997)
• Fluad® (Influenza Vaccine, EU 24MAY2000)
• Fluvirin® (Influenza Vaccine, 21JUL2006)
• Tamiflu® (Influenza, 27OCT1999)
• Viread® (HIV, 12AUG2008)
• Qutenza® (Postherpetic Neuralgia, 10JUN2009)
• CIMZIA® (Crohn’s Disease and Rheumatoid Arthritis, 14MAY2009)
• Cayston® (Cystic Fibrosis, 23FEB2010)
• Provenge® (Prostate Cancer, 29APR2010)
• Teflaro™ (Community-Acquired Bacterial Pneumonia (CABP) and Acute Bacterial Skin and Skin Structure Infection (ABSSSI), 29OCT2010)

“I will say that Mike has very high standards and it's a pleasure to work with him. You will be in good hands with him. He (and his team) have a very good reputation. I've known Mike for a long time - and have alot of respect for him. I just wanted to put in my two cents for whatever it's worth." --Biotech Consultant

“I have had an opportunity to work together with Mike on and off on multiple global quality assurance projects for several years now and is always impressed by his experience and professionalism both in dealing with the clients and communicating with the personnel at the audit site. These qualities, coupled with his depth of knowledge, attention to detail and calm approach to high-pressure situations make him an excellent auditor and a pleasure to work with. I would highly recommend Mike to anyone who is in need of reliable and experienced clinical research auditor.” --B. Iossel, RN, MS, CCRA; Osmos, Inc.

"I believe your organization would find InSite QA to be an asset to any team and I highly recommend them." --Bay Area Biotech Client

"I highly recommend InSite QA." --Seattle Biotech Client

“InSite QA remains my first choice when the need arises to seek additional GXP support and I highly recommend them for assistance with any compliance needs.” --Seattle Biotech Client

May 14, 2001 - Michael Donatelli accepted into the Cambridge Who's Who as a Life Time Member. See our Press Release.

April 20, 2010 - InSite QA begins publishing items of interest on Twitter.

January 25, 2010 - cGXP Consultants incorporates as InSite Quality Assurance, Inc. InSite QA is an industry leader in drug, biologic, medical device and computer validation compliance services. We are proud to offer compliance experts that have a depth of industry knowledge accumulated over 3 decades of industry experience.

 

Cost Analysis of a QAU

FDA/EMEA Inspections of Clinical Investigators

GCP Clinical Laboratory Audits

Common GLP Inspection Observations by FDA and EMEA

Common GMP Inspection Observations by FDA and EMEA

Creating Powerful Presentations by Insite QA

 

Now and again, the links below may be out of date and broken. You may notify the Web Master to assist us in keeping the links current.

	FDA Home Page Debarment List Restricted List Warning Letters NIDPOE Letters FDA Monitoring Guidance Compliance Guidance Manuals Financial Disclosure Guidance Document
	HIPAA NIH - HIPAA and Clinical Research
	Division of Drug Marketing, Advertising and Communications (DDMAC) Clinical Investigator Inspection List NIDPOE Letters
	EMEA Home Page EMEA GCP Inspections EMEA GLP Inspections EMEA GMP Inspections
	Clinical Trials in the US
	Office of Human Research Protections
	Travel Warnings
	The CFR and US Code (Here you will find links to CFR Titles 21, 42, 45, USC Title 18)
	ICH Guidelines
	Biotech News
	Federation of American Societies for Experimental Biology
	International Federation of Pharmaceutical Manufacturers Association

 

	Fell Travel - Tom and Karen are true travel pros.
	Zierer Visa Services - they are a fast, stress free, visa and passport service.

IRB Expedited Review Criteria (FR November 9, 1998 [Vol. 63, No. 216])