Our expertise
Domain Areas
- Clinical Operations & Trial Management
- Inspection Readiness
- Site Monitoring
- Study Start-up
- Protocol Authoring
- Clinical Supplies
- CRO Oversight
- Regulatory Operations
- Submissions Management
Services
- Advisory Consulting
- Process Optimization
- Change Management
- Systems Implementation Management
- Vendor Oversight
- System Capability Health Check
- Maturity Assessments
- Roadmaps
R&D Technology
- Electronic Trial Master File (eTMF)
- Risk Based Management (RBM)
- Clinical Trial Management System (CTMS)
- Investigator Portals
- CAPA Management
- Submissions Management/Archive
- Regulatory Information Management (RIM)
- Registrations Management
O'Keefe Life Sciences is a boutique consulting services firm, specializing in R&D advisory, business process and IT consulting. We bring a practical, experienced approach to our clients' projects, and driving to desired business outcomes is always top of mind.
We live at the crossroads of process optimization and digital technology execution. We deliver strategies that are implementable and realistic, and we can assist you with the implementations through our extensive experience and relationships with the leading R&D technology vendors.
Achieving maximum optimization
of your R&D operations is our primary purpose
Our Services
O’Keefe Life Sciences works with pharmaceutical, biotech, medical device and CRO organizations to optimize and ensure compliance of R&D business and technology capabilities. We bring a history of experience and success to our client engagements, in order to accelerate initiatives and get to the positive business outcomes desired. Our focus is one Clinical and Regulatory business domains, and the inflection point of business optimization/transformation, and the technology implementations that often are the underpinnings of those business changes.
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Capabilities
Governance Definition and Implementation – We believe that good governance doesn’t have to slow down an organization; in fact, it should speed up the pace of change. We have worked with our clients to define and implement (and in some cases, manage) governance models across the spectrum of organizational, systems, process and data.
Advisory Consulting – We have lived through and encountered nearly every scenario you can think of, and can provide our advice and experience to your specific initiative. Often an external review of your plan or current challenge is all that is required to confirm the approach or help define that approach
Process Optimization – Our deep domain expertise, coupled with decades honing our facilitation and analysis capabilities, enables us to not only facilitate current state and future state business process initiatives, but also be a source of industry knowledge and best practices to accelerate your timelines
Change Management – No initiative can meet the business outcomes without a structured, pro-active change management program. From organizational impact assessments, to communications strategy and execution, to a robust, just in time, role based training program, our Change Management capabilities will buy down the risks on your programs by increasing adoption and identifying and reducing the resistance within the organization
Technology Vendor Selection – We have led dozens of R&D technology vendor selection phases, from initial business case development, through initial requirements analysis, to vendor identification, RFP development, vendor scoring, final solution recommendation and revised business case and budget planning. We are a vendor agnostic organization, but have relationships and experience with the leading R&D technology vendors.
Capabilities
Systems Implementation Management – Systems implementations have become more and more complex, as the business needs have matured, often requiring multiple vendor partners, multiple stakeholder organizations, and an integrated plan to orchestrate the implementations. We have managed small 6-week implementations, and have managed and led complex, multi-year and multi-million dollar implementations, managing a matrix team to success deployments.
Vendor Oversight – More and more technology vendor organizations are transitioning to cloud based solutions which are configurable and based upon industry best practices. It is common to rely on just their services teams to implement. We have seen that a lightweight oversight and advisory model with a third party consultantcy significantly increased the quality of the deployment, reduces the burden on the business and IT resources, and significantly increases adoption.
System Capability Health Check – New business and technology capabilities often take time to settle in. We excel at doing process and systems health checks, to identify opportunities for optimizing the processes and configurations, to drive the desired business outcomes and adoption
Maturity Assessments – We have a robust and mature methodology for scoring our clients’ business and technology maturity, either across a department, or specific to a function such as eTMF. Utilizing interviews and documentation review, we interactively assess people, process, data and technology aspects of the capability, and derive maturity scores, as well as where that maturity lands against the market. From there, we jointly work with our clients to identify the desired maturity across factors, which becomes the basis for establishing a roadmap of projects to get to the desired maturity.
Roadmaps – As the business and IT capability landscape has matured and become more integrated, leveraging capability roadmaps is an essential process to ensure business and IT stakeholders understand the needs and dependencies, and map out the full set of initiatives required to achieve them. We recommend that roadmaps become a living activity and document, tied to your process and systems governance, so you can adjust to the ever-changing technology and business priorities and capabilities
A FEW WORDS ABOUT
O'Keefe Life Sciences
O'Keefe Life Sciences was founded by Jamie O'Keefe to address the market need for practical, niche business and technology consulting for Life Sciences R&D stakeholders. There is a significant need for consultative support which combines deep business domain expertise with program/project leadership, and strong technology vendor implementation experience.
Mr. O'Keefe has over 15 years of R&D management and IT consulting expertise, working with both top tier pharmaceutical firms, and early stage biotechs. Prior to founding O'Keefe Life Sciences, he established and led the R&D Consulting Solutions practice for Paragon Solutions/CGI Life Sciences, where he focused on helping drive adoption of business capabilities such as: submissions management and archiving; IDMP; electronic management of Trial Master Files and investigator interactions; and defining and implementing risk-based monitoring programs.
He has over 20 years of business and IT consulting experience, with the past 15 years focused in life sciences clinical and R&D. His expertise includes increasing efficiencies in clinical site monitoring and protocol optimization, as well as implementation of electronic Trial Master Files and clinical investigator portals. He is an active member of the Drug Information Association, where he sat on the Document Management SIAC working group for Trial Master File Reference Model recommendations.
Contact Us
Phone: +1 (201) 736-9443
Email: Contact@OKeefeLifeSciences.com
Address: Doylestown, PA
OKeefeLifeSciences.com