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Acquisition Management       | top ^ |

Calvert Laboratories, Inc. manages all contract acquisitions through a pre-award, award, and post-award process. Defining and identifying the appropriate laboratory services to meet the client's needs, as well as, regulatory agency mandates is the pre-award protocol development process. During the award process, the technical aspects of the studies are performed under strict quality and scheduling requirements. The post-award process includes the timely delivery of a regulatory-compliant scientific report.

Communicating every aspect of the study process is the cornerstone of the Calvert business relationship. Externally, all staff is expected to provide the client with timely and relevant communications focusing on key scientific and business issues. Internally, continuous communication fosters accurate understanding of the laboratory policies, procedures, and accomplishments.


Administrative Support       | top ^ |

Calvert Laboratories, Inc.'s administrative personnel use personal computers to create spreadsheets, compose correspondence, manage databases, and create scientific reports and documents via desktop publishing, and using digital graphics--support our Study Directors in the timely presentation of the client's scientific report.

All Calvert reports are standardized internally against company formats, competitively within the industry, and within regulatory agency guidelines for submission. In addition, our reports continuously fall within both internal and external reporting cycles for timely agency submission and competitiveness.

Client surveys are employed to ensure satisfaction with timeliness, scientific and regulatory acumen, and the written quality of the final report--the product of Calvert Laboratories, Inc.


Confidentiality/Security of Proprietary Compounds       | top ^ |

Test substance control as defined at Calvert Laboratories, Inc. encompasses a formal system for receipt, storage, and use of test substances. Experience shows that regulatory agencies expect the generation of a sound audit trail as key to test substance control. Additionally, our clients demand business confidentiality on novel proprietary substances. A high degree of due diligence is expected to prevent loss or misuse of very expensive test articles.

Calvert employs standard operating procedures to prevent error in identification of the test substance. Chain-of-custody systems in our facility demand the identification of the place and date of receipt of the test substance. Adequate labeling of test substance containers is of paramount importance. Measures are taken to check that what is received from the client is consistent with a packing list, material data sheet, or certificate of analysis. A receipt register is maintained by our Pharmacy Department and contains exact details of each shipment.

The laboratory facilities provide for the appropriate storage areas and conditions to meet our clients needs. Systems are established to respond if defined environmental control limits are exceeded. The level of scrutiny and access control to a storage area is documented and enforced. In addition, records are made of any removal of test substances, noting the measure involved. It is mandatory and good practice for a second person to check the identity of items dispensed, along with any associated documentation. Many of our procedures adopted to control test substances also ensure the safety of laboratory personnel.



Good Laboratory Practice Standards       | top ^ |

The Good Laboratory Practice (GLP) standards are federal regulations promulgated in the United States by the Food and drug Administration in 21 CFR Part 58 and the Environmental Protection Agency both for FIFRA in 40 CFR Part 160 and for TSCA in 40 CFR Part 792. The European Union (EU) countries and Japan have also adapted a version of the GLP standards.

The GLP regulations describe the minimal standards for conducting non-clinical laboratory studies that support or are intended to support applications for research or marketing permits for products regulated by FDA or EPA. These products include animal food additives, human and animal drugs, medical devices for human use, biological products, electronic products, or pesticide products.

In brief generalities, Calvert Laboratories, Inc. adheres to the following practices for compliance with the standards:

  • Sponsors are required to notify the Calvert Laboratories, Inc. that the study must comply with GLP.
  • Personnel records are available to prove there is adequate education, training and experience for performance of assigned functions.
  • Calvert management is identified to designate or replace the Study Director, to assure the presence of a Quality Assurance Unit (QAU), the characterization of test and control articles, and to assure the presence of adequate personnel, resources, facilities, equipment, materials, and methodologies.
  • Study Directors are designated as the single source of study control whom assures the protocol is approved and followed, that all experimental data are recorded, and that the GLP regulations are followed, and that all raw data, documentation, protocols, specimens, and final reports are archived.
  • Our QAU assures management that the facilities, personnel, practices, and records are in compliance with regulations; maintains the master schedule of studies; inspects each non-clinical study at intervals to assure compliance; reports findings to the Study Director and management; and prepares and signs a QA statement in the final report
  • Calvert's equipment has standard operating procedures (SOPs) describing their use, maintenance, and calibration.
  • All laboratory methods have written SOPs.
  • The Study Director must authorize all deviations from standard operating procedures.
  • Each Calvert study has a written protocol describing the objectives and methods for the conduct of the study.
  • All data is recorded in ink, dated and initialed; while any changes in data entries must be as specified.
  • All final reports contain a compliance statement signed by the applicant, the sponsor, and the Study Director describing deviations, if any, from the GLP regulations.



Environmental, Health, and Safety (E,H&S)       | top ^ |

Calvert Laboratories, Inc. is committed to managing risk and complying with Environmental, Health, and Safety regulations in the performance of its work. We express that commitment through E,H&S-related policies and procedures which are intended to protect the health and safety of employees and the public, and to prevent damage to property or the environment. 

Contract research and development frequently involves working at the limits of technical understanding and can generate unique risks. Calvert mandates that all personnel engaged in laboratory activities do so in a manner that proactively anticipates hazards, designs and implements effective controls, and complies with applicable E,H&S regulations. Our well-established, highly regarded E,H&S department assists in ensuring all experiments are conducted in a timely manner, at a reasonable cost, and in compliance with environmental protection, health, and safety requirements.



Facility Operations       | top ^ |

Laboratory science would not be performed in accordance with the demands of government regulatory bodies and our clients without the critical support mechanisms and the physical plant. Calvert Laboratories, Inc.'s Facility Engineering Department is charged with maintaining the laboratory's working environment in an operationally safe and sound manner. Under the direction of the Senior Engineer, the staff operates and maintains facility systems, including steam systems, air compressors, air dryers, chillers, condensers, motors, water treatment systems, fans, and boilers to provide building services such as heat, ventilation, air conditioning, light, and power for building operation. The department provides safe access to the facility by maintaining roads and grounds; and provides custodial services, landscaping, recycling and solid waste removal; and heavy equipment maintenance, repair and operation.

In addition, through the efforts of the department our AAALAC accreditation is continuously secured by meeting the parameters of the Animal Welfare Act; the National Research Council's Guide for Animal Laboratories; and the Good Laboratory Practice Standards.

Information Technology       | top ^ |

Calvert Laboratories, Inc. supports an active information technology (IT) program. Its primary objectives are to:

  • Establish control over facility computer use
  • Provide enhanced computer capabilities to staff
  • Protect the integrity, maintainability, and survivability of data
  • Develop better ways of gathering, storing, and reporting study data
  • Provide for routine maintenance and support functions of computerized networks and data platforms

In addition, Calvert supports a complete suite of PC-based software specialized for the pre-clinical phase of regulated product development.


Integrated Assessment Program       | top ^ |

Calvert Laboratories, Inc. implements the necessary feedback processes in its daily operations to support performance-based management. As such, our integrated assessment program which does the following:

  • Provides operational, technical, and business performance indicators to promote early identification and resolution of problems that may impact the company's objectives.
  • Contributes to ongoing improvements in performance, including driving the laboratory's agenda for investment and change.
  • Verifies conformance to established internal policies and procedures, as well as, government agency mandates.

In addition, regularly scheduled operations meetings, a "lessons learned" program based on the results of client visits and regulatory inspections, and our tiered-approach to the concurrence and signature approval process contribute to the management of laboratory operations.



Metrology and Measurement       | top ^ |

Measurements and observations are the building blocks upon which most laboratory research is based. Calibration ensures the integrity of measurements and is a fundamental component of the Calvert Laboratories, Inc. research program. The validity of measurements is dependent on the assumption that the equipment used to make the measurement is operating within the intended specifications.

Our calibration system ensures that all measurement and test equipment used in the company is calibrated regularly against reference standards. Laboratory personnel test, calibrate, maintain electrical, mechanical, electromechanical and electronic measuring, recording and indicating instruments and equipment for conformance to established standards. Audit and review of the calibration system is conducted using similar procedures as those applied to the laboratory operations.

Calvert has employed the Calibration Manager software package which combines database and report writing features. The equipment master allows for scheduling calibrations and preventative maintenance; assigning calibration forms, tracking standards; designating calibration procedures; and attaching procedures, pictures, graphs, and specification sheets to equipment records. The equipment history allows for storing information to document compliance; tracking dates, calibrators, reviewers and calibration results; tracking standards to allow reverse traceability; and attaching procedures, spreadsheets, certificates, and captured data for reference.



Records Management       | top ^ |

The purpose of records management at Calvert Laboratories, Inc. is to plan and implement a cost-effective system to identify, preserve, and make available the documentation created or received during the operation of our laboratories and/or the conduct of business.

Calvert's Document Center Coordinator ensures that record information is controlled, maintained, evaluated for historical relevance, and disposed of in compliance with legal requirements. Records can be in the form of paper, electronic, or other media such as laboratory specimens. Some examples of records include laboratory notebooks, logbooks, procedures, environmental monitoring/measuring information, correspondence, study files, electronic mail, and quality assessment reports.

Scientific Performance       | top ^ |

Scientific performance is the primary strategy objective of Calvert Laboratories, Inc. Performance is the basis on which our industry reputation relies, as does its capacity to attract highly skilled employees.

We promote scientific performance internally by being sufficiently flexible and reactive, encouraging autonomy and making creative thinking possible. The organizational principle recognized by Calvert is that of research project-teams. A team is of limited size to include: Study Director, Study Coordinator, Project Leader, and Research Associates. Those who collaborate on the team will pursue the scientific objectives of a clearly defined, signature-approved, and regulatory agency compliant protocol.

Finally, the guarantee of scientific performance is the "peer-review" and "quality assurance" processes that remains the cornerstone of study execution at the laboratories, and encompasses all of the components of Calvert's work. 



Training and Qualifications       | top ^ |

Calvert Laboratories, Inc. scrutinizes its laboratory training plan on an annual basis--identifying accomplishments to date, assessing future training needs, and developing training budgets to meet strategic and tactical goals of the company.

Skills-Based Training strengthens staff expertise and emphasizes compliance with government regulations, as well as, the performance of technical procedures in accordance with Standard Operating Procedures (SOPs). Trainees must pass built-in proficiency portions of technical modules and written examinations to ensure consistency among Research Associates.

Dual Career Ladders provides alternate career paths for laboratory, regulatory, and administrative professionals who choose to move up and/or out of their current tracks and be compensated by bringing value through innovation, ideas, and leadership in their respective tracks.

Job Rotation Assignments in the laboratory is an opportunity for the systematic movement of personnel from job to job or project to project, as a way to achieve objectives such as retention tools, preventing job boredom or burnout, training employees, and rewarding employees.

Laboratory Mentoring is another opportunity to gain insight and understanding in laboratory procedures and disciplines that is not usually available through more formal recruitment and training channels. The program is established for Research Associates and at least one senior scientist within each department. Mentors develop coaching and management skills and mentees learn more about the Calvert organization and new areas of scientific expertise.

Succession Planning is the cornerstone for ensuring that critical competencies are met in the laboratory. Ongoing pools of candidates are maintained in a state of readiness for contingencies (employee retention), organizational change (laboratory addition), and entering new markets (professional services).

Calvert Laboratories, Inc. continuously enacts the above-mentioned concepts for a more resilient workforce. Training and qualifications focuses on career development skills building and links it to the company's overall business planning practices.



Validation        | top ^ |

Regulatory agencies expect research organizations such as Calvert Laboratories, Inc. to be in control of all computerized systems, devices, and instruments to ensure the integrity of generated scientific data. Calvert demonstrates control and compliance by developing documented evidence of data integrity, system reliability, management control, and auditable quality.

Calvert validation programs employ the traditional and logical progression from specification through design requirements, preparation of written test plans, performance of tests, and review of the results. 

As a system is validated and placed in operation, measures are established to ensure a "validated state" such as the integrity of hardware and software, data, and associated documentation in compliance with company and regulatory agency mandates.

The necessary detail encompasses the following areas:

  • Operational Plans and Procedures
  • Training
  • Problem Management and Resolution
  • Service Level Agreements
  • System Management
  • Backup and Recovery
  • Configuration Management
  • Operational Change Control
  • Security Management
  • Performance Monitoring
  • Record Retention, Archiving and Retrieval
  • Business Continuity Planning
  • Periodic Review and Evaluation
  • System Retirement

   

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