Consulting Project Sciences
Vitale Scientific Associates’ Project Sciences team provides specialty services not offered by most consulting firms. Our client value lies in the ability of our project scientists to use emerging technologies to develop practical solutions to business problems centered on the need for improved scientific data and information.
Applied research is used to inform the management of business risk and reward associated with provision of consumer products or business-to-business products. The need for solid, reliable scientific data and information differs depending on the materials in use and the end use of the product. Sometimes the need for better scientific metrics is focused on the product quality and purity, while other times the need is rooted in process control or quality of information provided by supply chain agents.
Employing our training and experience in sampling theory, statistical applications, chemistry, physical testing and biological sciences as well as statistical process control and analytical quality assurance/quality control enables our project scientists to conduct a needs assessment in partnership with our client.
Anchored in sound science and years of practical experience, we evaluate each client’s needs to scale and focus the level of effort to fit the particular situation. While we do have a full corporate QA menu to offer – we recognize that in some cases a simple refinement in sample collection or measurement may be the ideal solution. Some of our clients have research directors in need of technical support, while others have a strong technical staff that need project oversight. In some situations our clients employ contract research providers and need assistance with oversight of these services.
No matter how experienced we are in a particular industry, we recognize that each client’s needs, and existing resources, are unique. Experience has taught us to assess pertinent information about the particular client, production line, packaging method, sampling scenario, process, laboratory, method, data structure, and type of information through a needs assessment.
We offer support at several service levels depending on the outcome of the needs assessment – a few examples:
Once the needs assessment is complete, specific research needs or needs for improvement of data quality may be identified. In the case that identified research objectives are identified, VSA’s project scientists can provide study plans based upon the study questions, the tolerance for error, and the subsequent type and quality of data that are needed. The research design is generated; including making sure that statistically informed sampling plans and interpretive strategies are established, and that data collection, testing methods, data reduction, acceptance criteria, statistical analyses and decision matrices are laid out in advance to assure an integrated, linear approach to reach the study objectives. Once the design is complete, subsequent program needs such as quality planning, technical specification development, and standard operating procedure development are directed by research management and provided by the QA oversight provider.
In this role, the VSA’s project scientist manages all aspects of a designed study or program of studies. Once the design and methodology is established, the manager assures that appropriate quality assurance planning and technical specifications are established. Depending on the size of the data set to be developed, the quality planning and specifications development may include and be integrated with an appropriate data management plan. Once the appropriate planning and specifications are in place, the project scientist uses these assets to identify and evaluate sampling and testing candidates. The final selection of service providers is generally provided by the client and is informed by the information provided from the Research Manager’s (RM) evaluation. Once the participants are selected, the RM arranges the subcontracting if needed and manages the work; providing schedules, budgets, technical support, planning, conferencing, reporting and other services as needed to assure that the objectives are met within budget and are on time.
Scientific Data Collection Quality Assurance Oversight (QA Oversight)
In support of research management, the project scientists at Vitale Scientific Associates provide quality assurance planning, technical specifications, and sampling procedures as described in the Research Management section. We also conduct training and third party oversight of the collection and handling of samples (or test materials), the transfer of custody of the test materials to the appropriate laboratory, the instructions given to the laboratory, the laboratory testing, and reporting. Sampling and laboratory audits and data validation are also provided within this role as needed.
Third-Party Sample Collection Auditing
A non-biased review performed by our project scientists of sampling procedures that are conducted on-site and in real-time, helps to identify quality deficiencies prior to generating study data. On-site auditing of sample collection procedures is effective in implementing real-time corrective action measures, and as such, is an integral step in ensuring quality data in a project life cycle.
Our auditors have experience in identifying data collection, sample procurement, record-keeping, and health & safety issues before they become problematic. Results of our audits can be used to evaluate sampler performance and can inform future contract awards for subcontracted employees.
Data Management and Interpretation
With a sound research design, quality assurance planning, technical specifications in place, and quality assurance oversight assuring sound sampling, sample handling and testing, data of appropriate type and quality are generated. VSA’s project scientists work with our clients’ personnel or VSA’s Information Technology group to assure that the data are integrated, organized, stored, normalized, managed, and retrieved appropriately, in a manner that gives you and the interpreter access and confidence in the data, its validity, and its history. VSA’s project scientists, along with its chemists, biologists, and metrologists evaluate the appropriateness of the data for its intended purpose, performing statistical analysis to develop findings and conclusions within the original research plan.
Regardless of your business, vendors and suppliers play a key role in your success. However, managing and administering the supply chain quality of vendors’ products and services can be an expensive, time consuming, and highly technical task. Let VSA scientists support you in your role by providing third party supplier management services.
Our consultative approach results in an accurately budgeted, organization-specific solution. The services we offer include:
- Vendor Technical Specifications Manual development
- Vendor Selection Support
- On Site Audits
- Product Specifications
- Quality Systems
- Control of Test Equipment
- Quality and Source of Raw Materials
- Control of Non-Conforming Product
- Corrective Actions
- Certification/Accreditation Review
- Reporting and Trend Analysis
- Licenses and Permits
- Validation Certificates of Analyses for Finished Products
- Record Maintenance
- Handling, Storage, Packaging, and Delivery