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The Kelly Group LLC

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Ellicott City, Maryland, US

About The Kelly Group LLC

The Kelly Group delivers practical, far-sighted consulting to life science and biotechnology firms that gets straight to the heart of your business or laboratory issues and delivers results by helping you improve the way you operate, reduce your costs, manage risks, leverage talent or fundamentally change the way you do business. We are all about helping small and mid-sized companies in the life sciences work smarter and grow faster.

Diversity Certificates

Small business

Our Services (19)


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Project Management

Price on request

Life science companies frequently juggle complex business projects under demanding timelines. The Kelly Group can be a key asset helping your organization develop and manage projects increasing the probability that your project will be delivered on schedule and within budget.

Organizations are continually challenged to meet business demands requiring projects to be completed faster and cheaper. Effective project management can address these challenges insuring successful project delivery.

Project management at the Kelly Group begins with our initial consultation to assess the current condition and identify the desired results; with this information we can establish the scope of our services. We work with you to establish project control processes and requirements, status reporting, logistical parameters and communication methodology. Through regular project reviews we provide status updates on intermittent milestones, planned activities, budget analysis and suggestions for process improvements.


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Change Management Services

Price on request

Success in business often depends on the ability to adapt to changing conditions. Too often, efforts to improve, adapt, or correct come up short because real change is hard.

Even under ideal conditions and with the best of intentions It’s human nature to resist change.

Organizations can significantly increase the probability of success by proactively managing the change process using a planned multistep approach. A planned approach to change management provides a structure that supports the individuals involved as they adopt new operations, approaches to business decisions, behaviors and ideas.

The Kelly Group specializes in supporting organizations’ management of change ranging from large scale business transformations to more focused and limited projects. The dynamic nature of business in the life sciences sector is such that organizations are changing at an increasing frequency as they respond to new regulations, legislation, cost pressures, and the implementation of new technologies.

We are effective because we take a systematic approach to understanding our client’s operations while considering the social impacts on those involved. We guide you to identify all the stakeholders, establish the gaps between the current state and your vision for the future, and then assist you identifying the methodologies required to make the transition. These methodologies include:

  • creating a consensus that change is needed;
  • coaching to provide the skills necessary to effect change; and
  • establishing a climate that sustains the change.


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Business Development Consulting

Price on request

Too often developing a business proposal, grant, or responding to an RFP is a side job for the technical staff in small to mid-sized life science companies; or if an in-house business development team exists it can quickly become overwhelmed with opportunities for growth. All three types of documents referenced above present opportunities to communicate you vision to funding agencies, investors, managers and employees. Augmenting your staff to professionalize the process increases the likelihood of success.

With over 35 years of experience preparing technical documents, journal articles, grant requests and contract proposals, the Kelly Group is well placed to augment your in-house proposal efforts from generating a basic template to fully outsourced proposal development.

  • Bid/no bid analysis
  • Document Template preparation
  • Strategic planning
  • Pricing
  • Technical Writing
  • Volume Management
  • Review Process Management
  • Technical Editing
  • Program Management


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Safety Pharmacology

Price on request

Translating in vivo animal data to the clinic can be problematic as evidenced by the large number of potential drugs that succeed in preclinical safety and efficacy studies yet fail in human trials. These daunting statistics make the selection of appropriate preclinical models one of the the most important aspects to drug development.

With over 15 year's experience overseeing large, complex in vivo research programs, the Kelly Group has the experience and expertise to guide you through the choice of appropriate animal models for your research and development efforts.


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Preclinical Study Design

Price on request

The adequate design of preclinical safety studies and the care choice of mode systems are vital to deliver results that justify a clinical trial. Preclinical studies need to be well designed, properly executed and the data correctly interpreted to be of value both scientifically and ethically. A well-designed protocol spells out the objectives of the study, the hypothesis being tested and study design including sample size and suitable controls.

Small biotech firms and startups often lack the resources to effectively transition from “drug discovery” efforts (efficacy studies) to “drug development” (safety studies). The Kelly Group provides consulting services to help you craft and creating your protocol methodology. Our efforts on your behalf include helping you to:

  • Identify the experimental variables that are to be manipulated
  • Establish suitable test parameters that accurately assess the effects of experimental variable manipulation,
  • Determine the most appropriate methods for sample acquisition and generation of the test data including toxicokinetic data.
  • Determine the appropriate dosing regime for your test article
  • Determine the appropriate methods for data analysis and statistical tests to be applied
  • Establish a realistic time frame for data collection and evaluation


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PK/PD Data Analysis

Price on request

The Kelly Group provides pharmacokinetic (PK) data analysis for discovery and preclinical studies using either a model dependent (compartmental) or model independent (noncompartmental) analyses. We calculate bioequivalence, drug exposure, and drug recovery data and will also provide assessments of PK/PD relationships. Our analyses iInclude:

  • Non-compartmental and compartmental analyses using client supplied raw data
  • Generation of relevant PK/PD figures
  • Written interpretation of PK/PD results including statistical analysis
  • Study design and clinical protocol consultation


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Technical Writing

Price on request

The Kelly Group works closely with clients who wish to supplement the efforts of their in-house team to generate reports, proposals, and journal articles. We plan, organize develop, write and edit these and other related technical publications. We work with you throughout the editorial process and can assist with:

  • Experimental design
  • Literature reviews
  • Methods delineation
  • Data analysis, and interpretation
  • Results and conclusions

We will assist you throughout this entire process and all phases of your project. We work effectively with members of your team to establish the scope of your writing and editing requirements to deliver a quality product on time. We bring rigor to your project to insure that your documents accurately reflect the significance, results and conclusions of your research efforts.


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Business Development, Marketing & Operations

Price on request

A strategic plan is a foundational document in any successful business; it lays out your goals and provides understanding as to why those goals are important. Good strategic plans establish a sense of direction, they are made up of measurable goals whose completion advances the organization’s mission.

The Kelly Group provides professional services to lead your planning process. Our efforts result in a strategic plan that encompasses your organizations mission and vision, details measurable goals and provides a timeline for execution.

We begin with a series of guided exercises to help your organization articulate its mission. This initial session is designed to provide an analytical framework for the planning process and facilitate an honest discussion of lessons learned and institutional priorities. Follow-on efforts are designed to identify key organizational systems slated for improved performance and together these efforts serve as the basis for establishing both short- and long-term goals.

The dividend from a quality strategic plan that has stakeholder buy-in and that is updated regularly is sustained business growth.


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Marketing, Communication & Graphic Design Services

Price on request

Marketing, Communication & Graphic Design Services


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Editorial and Writing Services

Price on request

Editorial and Writing Services


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Drug Discovery & Development

Price on request

Drug Discovery & Development Services


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Pharmacology & Toxicology

Price on request

Pharmacology & Toxicology Services


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Pharmacology

Price on request

Pharmacology Services


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ADME/DMPK Studies

Drug Metabolism and Pharmacokinetics
Price on request

ADME/DMPK Studies Services


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Biology

Price on request

Biology Services


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Animal Models and Studies

Price on request

Animal Models and Studies Services


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In vivo Pharmacology Studies

Price on request

In vivo Pharmacology Studies Services


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Business Development Services

Price on request

Business Development Services


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Business Operations and Logistics Support

Price on request

Business Operations and Logistics Support Services


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Gregory Kelly

Consultant

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