Tranquil's ultimate goal is excellence in the clinical trial process and bringing trustworthy products to patients.
Tranquil clinical research was created to ensure that the entire clinical trial, device, and drug development process is conducted with ethics and the patient in mind first and always. This business model ensures that our clients clinical trial is adherent to the highest level of quality and integrity in the services we provide.
Our Phase I facility is located in the most diverse city in the US. Patient safety is our #1 priority. We offer the following patient centric services:
Our dedication and passion for our projects is clearly and repeatedly demonstrated through every clinical trial we have completed and are currently working on. Key operational principles that ensure your project is safe with TCR are:
Executive oversight with issue escalation and communication with you
Therapeutic expert/strategic advisor training and involvement for your study
Low employee attrition rate because we treat our employees with the utmost respect and value, and provide continuous training and support for our staff
TCR works diligently to ensure we are experts in our therapeutic indications and regulatory requirements. Quality, ethics, Good Clinical Practice (GCP), Code of Federal Regulations (CFR), therapeutic indications and our core values are reinforced in monthly teleconferences and twice-yearly face-to-face meetings We have an employee-for-life philosophy, which includes full benefits and great work/life balance, to ensure that team members will be at your service for the duration of your project. We are a nimble organization that can out compete giants with our focus on patient safety, efficient trial management, quality project deliverables, central monitoring, and most importantly, flexible and excellent working relationships with our clients. The key to our success is our ability to become an extension of the sponsor and work with our sponsor in a consolidated team effort.
At Tranquil we have worked diligently to harbor an environment of collaboration, teamwork and always doing the right thing. This results in the highest quality of work with the most efficient use of time and resources. We believe in the two principles “touch it once” and “always do the right thing”. This philosophy results in our service being performed right the first time.
A Quality Driven CRO with the following capabilities:
Phase I Unit Project Management
Quality Assurance Consumer Health Care
Tranquil Clinical Research specializes in the following areas:
Phase I – CRU
Phase II studies
Complex therapeutic indications
Device and Registry studies
Expert Therapeutic Training:
Each study is assigned an expert therapeutic clinician to train our project team
Strategic Advisor for each indication
1% employee attrition:
Lowest industry attrition
Unmatched Benefits Program
Bi-Annual employee development: Disney & Nasa
Monthly employee training
Focus on Quality Deliverables:
Quarterly Site Status Reports to each site
Employee Service Manager ensures quality metrics
Executive Oversight meetings quarterly with each client
Results in on time, high quality deliverables.
No project delays due to employee turnover.
Results in highly trained project team = risk mitigation on each project.
Patient Centric Phase I Unit
Focused on Diverse Patient Populations
Patient Outreach Coordinators within our organization to help facilitate recruitment of diverse populations
24/7 on call ACLS Nurses
Best patient accommodations - category IV hotel next door and 2000 square foot "Tranquility Lounge"
Located in the most diverse city in the US, surrounded by 11 different university/college systems and 1 block from Level II trauma center
Clinical Trial Monitoring refers to the act of monitoring the conduct of a clinical trial, ensuring that the trial is being conducted within compliance of regulations, protocol, SOP (Standard Operating Procedures) and GCP (Good Clinical Practice).
The sponsor representative or clinical research associate (CRA) is responsible for the monitoring of a clinical trial by visiting the clinical trial site in person at intervals set forth within the monitoring plan for a research study. The sponsor ensures the proper execution of the clinical trial and extent of the monitoring needs on the basis on a few considerations including objective, design, purpose, blinding, complexity, endpoints, and size of the trial. Irrespective to any case or any clinical trials, there is always a need for the on-site monitoring before, after and during the clinical trial. Clinical Trial Monitoring is performed to ensure the safety, well-being and rights of the subjects participating in the clinical trial are protected. It also makes sure that the data collected after the trial is accurate and credible in every aspect. The process of the excellent clinical trial monitoring consists of the verification of the informed consent process by evaluating the affiliated documents, conduction of the study within the protocol, and source notes. The sponsor can even appoint any person with the appropriate training and clinical/scientific knowledge to monitor the clinical trial.
The process of excellent clinical monitoring is a vast point to look-upon and study. The clinical monitoring is even costly as well as a critical aspect of the clinical trial. The primary objective of the excellent clinical trial monitoring is enhancing the safety of the subject along with improving the performance of the site with deeper insights. The overall communication of the site and investigators with the ethics committee must be reviewed to make sure that the safety updates, serious adverse events, protocol amendments, and more are submitted to the committee as per the guidelines and regulations. Proper storage of the study drug is even maintained to ensure the usage of the study drug in correspondence with the clinical trial protocol.
According to the US Food and Drug Administration’s centre of drug evaluation and research, the top faulty categories caught by various clinical monitors are:
Failure to follow up with the investigation protocol
Inadequate or unclear informed consent forms
Failure in reporting the adverse events
Failure in accounting for the arrangement of study drugs
Failure in keeping the accurate and sufficient records of the trial
At Tranquil Clinical Research, we provide full Project Management support for all our clinical trials. A Clinical Project Manager (CPM) is assigned to each study as the primary point of contact with the Sponsor. Our CPMs engage with the client from the beginning to better understand their goals as well as offer solutions to position the clinical trial for a successful outcome.
We deploy reverse engineering to evaluate endpoints, study deliverables, study objectives, key risk indicators, risk assessment and risk mitigation data. This analysis provides the information we need to ensure effective management and milestones prior to study deployment. The CPM ensures each study plan is tailored to meet the specific needs of the Sponsor and works with the project team to communicate Sponsor expectations and meet goals for study deliverables. Our Project Management Team provides flexibility in planning, executing, and setting achievable milestones that meet the expectations of our clients.
Our Project Management Team will ensure your study is planned, executed and well-coordinated to achieve your goals and objectives. Contact us for further information on how we can serve the Project Management needs for your study.
Patient safety is paramount to us at Tranquil Clinical Research and this philosophy is evident in how we execute the Medical and Pharmacovigilance services we provide. Our Pharmacovigilance and Safety Team at Tranquil Clinical Research ensures that the safety of clinical trial subjects is closely monitored.
Our safety team has SAE processing and query generation experience across multiple studies and therapeutic indications. We utilize a safety processing system that initiates a cascade of seamless steps that enable a timely query resolution process. Please contact us for more details on how we can provide the top-notch Pharmacovigilance and Safety oversight your study needs.
Tranquil Clinical Research offers complete Data Management services to best fit each client’s needs and budget. Data Management is a key component of the clinical study to ensure reliable and efficient data collection as well as availability of data for analysis. At Tranquil Clinical Research we allow innovation and creativity to drive how we proffer solutions for our clients. We ensure your EDC system meets the FDA GCP 21 CFR Part 11 compliance requirement for all our clinical trials. Our EDC systems have capabilities for:
User Acceptance Testing
Serious Adverse Event reconciliation
Functional reporting tools
Our experts will analyze your study design and budget to make the best recommendations for an EDC platform to best serve your needs. Reach out today to find out how Tranquil Clinical Research can implement our strategies for efficacious management of your data!
At Tranquil Clinical Research, our team is highly knowledgeable in global Regulatory laws and requirements that guide the conduct of clinical trials. We understand FDA requirements for clinical trials and work with global partners to ensure a shortened timeline from drug discovery to approval. Through close-knit collaboration and long-term experience with regulatory bodies, we will ensure rapid regulatory submissions for your study every step of the way. Our rapid start up process and effective communication with relevant authorities positions your study for a smooth ride on its journey through the clinical trial process. Reach out to us today and let us bridge the gap for you from the laboratory to market.
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