We Are Committed to Your Health
Well-trained staff can make the difference between clinical trials that are conducted successfully and those that are not
GCP regulations and guidelines govern clinical trials, and a thorough knowledge of procedures at every stage of the clinical trial process is essential
Site Management Services
L&C offers the full oversight of project management from global Phase I through Phase IV clinical trials in all therapeutic locations. In addition, direct communication with the appropriate Project Manager is of paramount importance in order to streamline the process of planning, fine-tuning and executing a clinical trial correctly.
Promoting Excellence in Clinical Trials
We provide the pharmaceutical industry with access to targeted study populations as well as accurate, precise, and quality data.
We have nearly 25 years of experience connecting breakthroughs to the real world. And with our expert understanding and advanced technology to support clinical research, no one is better equipped to move your discovery forward.
International Clinical Trial Manager
L&C can develop operations in the geographies (Asia, Europe, and Latin America) that are most important to clinical research. L&C staff speaks many languages, our members are familiar with local policies, regulations and customs and have a global network of resources to support clinical development programs.
L&C investigators work on studies for the world’s leading pharmaceutical, biotechnology and medical device companies. The studies span all phases of the drug development cycle and are in every major therapeutic area.
This section of our website will enable you to learn more about becoming a L&C Investigator.
Clinical Study Investigators
Clinical investigators play a vital role in bringing new and potentially life-saving medicines to markets faster, which in turn enables millions of people all over the world to live longer, healthier and happier lives.
Register as an Investigator
If you would like to include your information for future clinical trials, click on the links below and register your information. This information will be used by L&C staff to identify potential sites.
Register for Preclinical
Register for Phase I
Register for Phase II-IV
L&C uses only the services of Central IRBs this helps us meet our deadline goals of IRB submissions with a quick turnaround time of 3 days. The standard turnaround time of Central IRB for expedited review of research sites is one business day. This turnaround time applies only when a submission is complete and — if there is any – follow up resolved. Additionally, site approval will not be provided until the study has been approved and the informed consent finalized. Site submissions are processed by expedited review daily or may be referred for a full board review under certain circumstances.
L&C has prepared numerous Standard Operating Procedures (SOPs) to conduct clinical trials according to GCP guidelines. SOPs are available in the areas of: Administrative, Clinical, Data Management, Laboratory, and Pharmacy.
Our contracts and budgets have a turnaround time of less than 72 hours.
L&C has created the internal policies for contracts/budgets with all pharmaceutical companies. The overhead rate charged to all sponsors is between 25 and 30%. This is based on last year’s financials, and the rate is revised annually.
Clinical research, a process that generates, collects, and analyzes large amounts of data, lends itself naturally to the digitization process. The adoption of information technology in clinical research has been rapid when compared to other industries. L&C will promote the use of these technologies to achieve excellence in clinical trials.
Our team has experience with many of the leading Institutional Review Boards (IRB) and clinical trial management systems and has worked with several software vendors to provide guidance during their development cycles. We help clients through the system selection process, support pre-implementation planning activities, can lead or support the implementation of the selected software package and provide post-implementation support to optimize how the system is used. In addition, we support related organization redesign, change management and training needs to ensure smooth adoption of the system.
Clinical Research Billing
Our team has the specialized regulatory and financial expertise to help institutions successfully navigate the complex billing rules and regulations of clinical research. We conduct assessments of the clinical trial budgeting, charging and billing process and provide solutions to improve efficiencies, cost reimbursement and compliance.
Responsible and Ethical Research
L&C provides strategic advice, education, policies, and practical operational solutions to help institutions conduct their research in a responsible and ethical manner. We help develop reasonable and compliant policies to identify, analyze, and manage conflicts of interests, as well as assist with investigations.
Human Research Protections and Institutional Review Boards
We provide comprehensive assessment and implementation services to strengthen compliance and improve the efficiency of human research protections and Institutional Review Board (IRB) operations.
On-Demand Interim Staff and Management Support
We provide our clients with experienced staff to temporarily fill vacant positions or assist with periodic peaks in workflow. We have a team of seasoned professionals who have served in management and staff positions in clinical trials offices, IRBs, research billing units, and held numerous administrative positions. We strive to reduce backlogs, improve service levels, and assess staffing levels and skill sets for permanent candidates.
1. Pre-Study/Qualification Visit
L&C initiates a complete assessment of each clinical research site, capabilities of staff and evaluates the site’s ability to adhere to FDA regulations, Good Clinical Practices (GCP’s) and the overall conduct of clinical trials.
2. Site Initiation Visit
L&C provides full initiation of the clinical research site which includes but is not limited to, review of protocol, regulatory documents, Case Report Form, enrollment requirements, investigational drug and responsibilities for the conduct of the clinical trial.
3. Interim Clinical Monitoring Visit/Site Monitoring Visit
To ensure quality, L&C conducts ongoing clinical monitoring throughout the conduct of the clinical trial. Activities include: informed consent review, eligibility verification, Case Report Form and source documentation review, data retrieval, ongoing maintenance and review of regulatory documents, assessment of protocol adherence and drug accountability.
4. Close-out Visit
Upon completion of the clinical trial, L&C provides final retrieval of all data, resolution of data clarification queries, assessment of regulatory documents, review of site regulatory obligations, investigational drug accountability and return.
Our clinical research facility is looking for volunteers for the following clinical trials:
- Diabetes I
- Diabetes II
- Acne Vulgaris
- Atrial Fibrillation
If you suffer one of these illnesses please contact our office so we can help you and you may receive a compensation for the time and travel.