Our consultants support large and small laboratories, from designing / documenting operational workflows and drafting SOPs / forms for start-ups, to offering advice on process and equipment optimization for mid-size labs, and re-imagining space, materials, and operations for labs anticipating a significant increase in volume.
Software is the backbone of any efficient laboratory, so BioEvolution Labs is well-equipped to provide a range of LIMS support. Our consultants meet with users to understand their needs, draft user stories, refine product backlogs, provide details to software developers, and offer integration guidance. If your lab is still deciding on a software solution, BioEvolution Labs can also advise on a “build or buy” evaluation.
BioEvolution Labs has consultants who have experience starting customer call centers from the ground up, accommodating teams as small as 1-2 that are structured to grow into groups of 50+ agents. We can assist with selection and implementation of virtual call center software, provide requirements and optimization guidance for customer relationship management software, and design / document operational procedures.
After technology transfer from R&D to the Clinical team is complete, our consultants can assist with designing and documenting the test validation process in a way that meets CAP, CLIA, and NYSDOH guidelines, with FDA-approval in mind. Our Clinical Lab Scientists can execute the validation process and train new team members as needed.
BioEvolution Labs has Quality Assurance consultants who are experts in CAP, CLIA, and NYSDOH regulations, and are also familiar with ISO and FDA standards. Whether you are pursuing new licensure or preparing for an inspection, our team has you covered with Mock Audits, procedure & document review, inspection of personnel folders, and guidance on submitting to various states and agencies.
One of the most important questions when starting a lab or launching a test is: “How will we get paid?” BioEvolution Labs can assist with the design of operational workflows for reimbursement, as well as provide advisory services in best practices, or when medical billing challenges arise.
When it comes time to bring the validated laboratory developed test (LDT) to market, BioEvolution Labs is your top partner at launch. Our team can structure a detailed project plan, lead meetings with key stakeholders, monitor adherence to schedule, and most importantly, help design and operationalize the commercial workflow.
BioEvolution Labs consultants are trained in project management and have experience with both large and small projects. Our team can support the design of test requisition forms, test result reports, client-facing documents, specimen transport kits, and much more.
Many of our consultants are Clinical Laboratory Scientists licensed in the state of California, so whether you are looking for guidance from a CLS, lab management best practices, or licensed personnel to train the team on how to run your test, our experts are here to help.
Perhaps the most essential, yet the most overlooked aspect of launching a commercial test is the experience for the customer. Our team has seen first-hand the reception of many different tests in the market, so we know what to anticipate. We can assist with designing the end-to-end workflow from the customer perspective to work out any operational challenges prior to launch, as well as drafting FAQs for the customer service team to use post-launch.
Many of the consultants in the BioEvolution Labs network have experience with relocating or building laboratories. We are happy to share what has worked and what to look out for when relocating or building from the ground up, and can also help draft the project plan, equipment lists, and advise on the best layout to support an existing operational workflow.
Our consultants have experience managing shipping and receiving all kinds of biological specimens via commercial carriers, airline transport, local couriers, and nationwide couriers. We can help structure an operation that closely tracks samples in transit and optimizes delivery / receipt to meet laboratory needs.
There will always be complex questions that require extensive research and investigation into “best practices”, as well as ambiguity in requirements that can spark debate even among senior leaders. Partnering with an external group to navigate a path forward when these scenarios arise can alleviate stress on the internal team and free up resources for more important tasks, while ensuring you reach the correct conclusion.
It’s helpful to have extra hands and minds available to support a team on a deadline, especially ones who have done it all before. BioEvolution Labs has project management experts who are ready to support your team by completing small-scale projects independently to accelerate timelines, or by creating a detailed project plan with deliverables and closely monitoring the team’s progress toward the goal.
Many entrepreneurs are experts in their life sciences product, business, and market, but have never before been tasked with building a laboratory from the ground up. If you are asking yourself, “Where do I even start?”, then BioEvolution Labs’ full-service laboratory setup package may be the perfect solution for you.
For laboratories that already have a core team of professionals in place to support operations and future growth, BioEvolution Laboratory Consulting offers a blended hourly rate for simple advisory services. Our team of consultants has seen nearly every type of situation that can arise in a clinical laboratory, and we are happy to share our guidance and knowledge when challenging issues arise. Rather than spending hours researching the answer to a question, or trying to reach an external subject matter expert to get their opinion on a matter, let us poll our network of individuals who have seen the scenario first-hand. Share our contact information freely with your staff so they can call with any questions they may have, or consolidate the team’s inquiries and set up a regular monthly meeting to review any gray areas – we are standing by to support your business long-term as it grows!
BioEvolution Labs offers support in the execution of projects both large and small. While smaller projects can often be completed by a single consultant with minimal client contact, larger projects may require a detailed project plan and a team of stakeholders assigned to participate in project execution.
Our consultants can assist with the following types of small projects:
BioEvolution Labs can assist with the following types of larger projects:
We are also pleased to offer project plans tailored to meet your specific needs.
For projects lasting several weeks or longer, the team at BioEvolution Labs will meet with senior leadership to determine the services needed to complete the requested task prior to engaging the client stakeholders:
The consultants at Bioevolution Laboratory Consulting have many years of experience building laboratories “from the ground up”. If you are unsure of where to start when it comes to setting up a laboratory, let us do the heavy lifting!
For a full-service laboratory setup, BioEvolution Labs draws from our pool of consultants at various points in the project to ensure that the assigned individuals are specialized and experienced with the task at hand. To secure this flexibility and simplify invoicing, we offer a blended hourly rate and monthly retainer fee.
The following items are included in each full-service lab setup package:
BioEvolution Laboratory Consulting is a network that is focused on helping clients to efficiently connect patients with the healthcare solutions they need.
