ClinSmart is a full service Clinical Research Organization committed to providing a wide range of clinical development services for our Clients. Our team of dedicated professionals provide a personalized approach to assisting you with your clinical needs. While we are fairly “compact” in size, we have the ability to be more responsive to your needs and more economical than larger CROs.
The ClinSmart Team Dedicates Itself to the Following Three Qualities:
Everyone from the CEO to the office administrator knows your study.
Every ounce of effort conducted on a study by a ClinSmart member contributes to two things: understanding the study on a profound level, and making sure it’s successful.
At the end of the day you hire a CRO because you need a specialized team who can achieve your key success metrics on time and on budget.
ClinSmart is a certified member of the Minority Supplier Development Council (MSDC) and the Minority Business Enterprise (MBE).
The Safety Monitoring You Need to Minimize Trial Risk
Our team collaborates to minimize risks with effective monitoring, assessment and reporting of safety information throughout the duration of your clinical program. Our pharmacovigilance services include:
Case processing for clinical trials, post-marketing, literature
Development of Risk Management Plans and Risk Evaluation and Mitigation Strategies (REMS)
Safety reviews of Clinical Protocols
Periodic report preparation
Manage and process adverse events documentation
Maintaining Compliance Every Step of The Way
Without ensuring all Regulatory Aspects are appropriately handled, all of the diligent work in developing and planning a trial will be wasted.
ClinSmart keeps compliance at each step of a project regardless of whether our Regulatory Services are being engaged on a project or not.
We are ready to work with your team to analyze the regulatory aspects of your upcoming project.
Compliance services ClinSmart provides includes:
Acting as a regulatory agent with FDA on your behalf
Develop and/or review Regulatory Strategies
Organizing Pre-IND and Pre-NDA meetings and submissions
Prepare eCTD and review submissions to the FDA and electronically submit them through FDA’s ESG.
Coordinating special FDA meetings including End of Phase II meetings and Special Protocol Assessments as may be required
Auditing for pre-approval inspections and general cGxP compliance for clinical sites, manufacturing sites, and packaging sites
Overseeing QA review and release of all data
Always Thinking Three Moves Ahead
Bringing a product to market approval is a daunting task. Our clinical development services and solutions are built upon the idea that no two client engagements are the same. From study design through product launch and beyond, ClinSmart is the only resource you need.
We help clients focus on the most critical aspects of early clinical development through use of predictive analytics to provide realistic probabilities of success.
Our goal is to help you bring new products to market which will ultimately improve the quality of life for all.
Planning for Time. Planning for Budget.
Encompassing the entire clinical trial process is a need to complete projects on time and on budget. We have a golden track record for accomplishing this for IND Preparation and Phase I-IV studies in a variety of therapeutic indications and geographies.
ClinSmart can manage your project from start to finish. All project management activities are conducted in compliance with the study protocol, project management plan, standard operating procedures, ICH-GCP and other applicable regulations and guidelines.
We strategize to accomplish the following objectives when taking on a new project:
Develop and maintain timelines and resources
Communicate effectively with Sponsors and study support organizations
Organize and lead scheduled project team meetings
Risk management & contingency planning
Establish and maintain study deliverables
Oversight of the scope of work and budget
Troubleshooting and resolving study related issues
It All Comes Down to Numbers
Your clinical study has an overwhelming amount of moving pieces, which means an overwhelming amount of data sources to track and analyze. Let our statistical programming team assist you in managing the quantitative aspects of an upcoming project.
This team takes a strategic approach to providing operational statistics for clinical research and development. Our expertise allows us to deliver the high-quality output required for every aspect of drug development including the statistical material you need for study reports and regulatory responses.
Statistical analysis plan development
Sample size & power calculations
Randomization code design & execution
Coordinate data management & statistics
Perform Interim & Final Statistical analyses
Data package development with validation of tables & listings
Proper Information Management Saves Valuable Time
A single clinical trial will encompass thousands of datapoints. Having a plan in place on day-one to organize and track information efficiently will save hours of work, and is sometimes the difference between a project being completed on time. ClinSmart is ready to assist in collecting, managing, interpreting and preparing your clinical trial data. We have an experienced team of data professionals and industry-leading technologies designed to meet your needs. We offer:
CRF / eCRF design and printing
CRO Connect Partnership with DataTrak
Data Management Plan creation
Development of electronic validation rules and edit checks
Electronic and manual review
External data integration
Quality control and assurance
Generation of status and ad hoc reports
Database lock and audit
Database transfer to Sponsor in requested format
Assist in generation of final tables and listings
Assembling the Words That Bring Meaning to Your Work
We understand the complexities of writing in a highly regulated environment and the challenges of varied requirements of different regulatory agencies. ClinSmart is experienced in preparing regulatory documents to support drug, biologics, device, and diagnostic submissions to regulatory agencies.
Protocols, Charters, and Informed Consents
Clinical Trial Reports
Scientific posters and papers
Clinical manuscripts to support marketing and journal publications
All NDA section summaries
• Generic formulation development
• Formulation Development for FIH studies and various clinical phases
• Preclinical Formulation Development
• High Potent and cytotoxic compounds formulation development
• Formulated capsules – powder blend/granules in capsules
• Modified release capsules- beads or mini tablets in capsules
• Liquid filled hard gelatine capsules
• Solution and suspension
• Powder for oral solution or suspension
• Parenterals, Ready-to-use liquid and lyophilized formulations for IV, IM and SC administration
• High Shear Wet granulation ( Rapid Mixer Granulator)
• Fluid bed granulation ( Low Shear Granulation)
• Direct compression
• Fluid bed drying
• Wurster coating (palletization)
• Functional and Non- Functional Tablet coating
• Hard Gelatin Capsule
• Solid Orals: Capsules and Tablets with different release profiles (immediate, delayed, modified), effervescent tablets, chewable tablets, dispersible tablets, pellets with different release profiles, pellets into tablets.
• Liquid Orals: Ready-to-use solution/suspension, powder for solution, powder for suspension.
• Parenteral: Ready-to-use liquid and lyophilized formulations for IV, IM and SC administration
• Assay, purity, dissolution testing method development
• Forced degradation studies
• Analytical method development for drug product
• Stability studies to support development
• Cleaning methods for drug products
• Method transfers
• Excipient Compatibility Study
• HPLCs (UV and PDA detectors)
• Water by KF
• Viscosity Measurement
• Dissolution study ( USP I and II)
We Can Help Move Your Drug Development Process Forward
The development of an Investigational New Drug Application (IND) is no simple matter and is required by the FDA prior to any testing of a product in humans. Navigating this piece of the drug development process can get many teams stuck before they've even really started. IND Preperation requires understanding of FDA rules and exceptions, focusing on removing blockers from the process, and maintaining forward momentum.
If you're facing an upcoming IND submission, we'd like to hear from you. We can help you understand your options, present applications to the FDA, and build proof of concept studies.
If you're the head of your clinical study, your sites are the hands and feet. Effectively managing these touch points between your team and your subjects is critical to your success. We offer experience in managing partner sites around the globe.
Our site management services include:
Conducting telephone interviews to determine interest, availability & expertise
Investigator confidentiality agreement
Conducting site qualification visits
Evaluating sites for clinical trial participation
Preparing Site Qualification Visit Reports
Supporting investigator meetings
Monitoring interim visits, including source data verification, IRB/SAE document review and CRF corrections
Close-out visits, including final study binder review, final drug accountability and return, and review of study documentation
Investigator contract/budget negotiation and management
Using tools and metrics during Start Up to ensure only the best investigative sites are selected
Continual communication and training with investigators and site staff
Trial Master File setup and management.
And of course, ongoing trial site management.
ClinSmart CRO has not received any reviews.
ClinSmart CRO has not received any endorsements.