All projects require superb coordination and communication which is provided by our team of Project Managers. This highly experienced team is responsible for overall project management and client relationships.
Our PM team’s motto is "Client satisfaction and ensure timely deliverables"
The key responsibility of project manager includes:
- Develop a study schedule with tentative date of key deliverable
- Manage deliverables according to change in plan
- Conduct the feasibility assessment and the study execution plan
- Responsible for and make sure that all the commercial aspects are complete before initiation of any activities.
- Coordinate and assign tasks to internal study team members
- Provide regular updates on key milestones to sponsors
- Responsible to coordinate with internal department for feasibility of new inquiry/study
- Set up regular communications through email or phone conversations with sponsors
- Act as the interface between sponsor and internal department for effective communication and ensure the activities are progressing smoothly and in the proper direction
- Efficiently handle matrix the processes involved in the successful execution of a study from pre-award till the final report is delivered to the sponsor.
- Our project managers are very adept at identifying and prioritizing risks using and established processes
Accelerated First To File (A-FTF)
Cliantha has experience in successfully executing multiple Accelerated FTF studies at a time for multiple sponsors always achieving the desired filing date by each sponsor.
In fact, Cliantha has successfully executed an A-FTF for FDA bioequivalence studies in as little as ONE week through meticulous coordination between the respective teams and sponsor. Through the entire process we accomplish the deadline and delivered the report without compromising any ethical standards of our processes. This was proven by FDA inspection without any observation.
We have experience of conducting studies with diverse dosage form and route of administration as below:
- Tablet (IR, ER, DR, OD, EC, Chewable, Sublingual)
- Capsule (Soft Gel, MR)
Hill Top Research has been conducting standard setting dermatology research for nearly 70 years. Hill Top/Cliantha has the combined ability to conduct Phase I patch studies in the US, Canada, and India.
With our DermRx division in North America and our partners in India, we are able to conduct a wide variety of safety and efficacy trials for topical drugs. These trials can be conducted in a controlled in-house environment or on an outpatient basis.Cliantha/Hill Top has amassed a wide variety of speciality scientific instruments used in the conduct of our dermatology and personal healthcare trials.
Phase I Safety Trials
- Acute Irritation or Primary Irritation (24-hour and 48-hour patch test)
- Cumulative Irritation (14 day and 21day)
- Contact Sensitization (Human Repeat Insult Patch Test [HRIPT])
- Patch Testing
- Pharmacokinetic Studies with capacity to house up to 48 subjects
- Transdermal delivery systems (irritation, sensitization, adhesion)
- Transdermal Patch Cold Flow Studies
- Actinic Keratosis
- Atopic dermatitis
- Seborrheic dermatitis
- Head Lice, Scabies
- Hormone replacement therapy
- Pain (Lidocaine)
- Fentanyl Transdermal System
- Rotigotine Transdermal
- Buprenorphine transdermal
- Smoking cessation
- Taste testing
- Topical antibiotics
- Wound healing
- Wound healing
- Cold Sores, Herpes Labialis both spontaneous and UV light induced
- Diaper Rash
Hill Top Research
Hill Top Research has a legacy of 70 years planning, conducting and analysing Dermatology studies for pharmaceutical, biotechnology, generic and personal healthcare companies. We have expertise in conducting the following clinical research.
- Patch testing (primary and cumulative irritation, sensitization)
- Vasoconstriction (Skin Blanching)
- Phototoxicity and photo allergy
- Antiperspirant and deodorant*
- Hyperhidrosis Laser Treatment
- Skin Biopsies
- Skin lightening
- Pediatric (diaper rash, disposable diapers/wipes, safety, infant eczema, product taste test)
- Acne (cosmetic cleansing, anti-acne studies, OTC and Rx acne product studies and trials)
- Sunscreen safety, durability and use trials in both adults and children
- Mildness/moisturization (FCAT/LCAT studies, long- and short-term dry skin/moisturization)
- Feminine hygiene (tampon and incontinence)
- Cold sore, Herpes Labialis (naturally occurring and UVR-induced)
- Head lice
- Ocular safety (sting and instillation for topical products, home-use for cosmetics)
- Wound care/wound healing (dermabrasion model, incisional wounds, tape-stripping, and SLS challenge)
- Dry mouth
- Footwear, Athletic Clothing testing.
- Fitness Wristbands and “wearables”
- Chapped lips
- Cleansing Efficacy (make-up removal)
- Cosmetic Use
- Foot care, cracked heel
- Board Certified PI’s in Ophthalmology, Dermatology, Podiatry, Paediatrics, Family Practice, OB/GYN.
- Our Medical Director and Associate Medical Director are also Certified Principal Investigators by ACRP.
- Experience with Device Studies
*Our Deodorant studies have included as many as 110 subjects as a single group in a validated, regulated, environmentally controlled chamber. We have 5 HTR trained qualified “odor” judges.
In addition to the above we can offer consulting services in Dermatology for HRIPT, Vaso Assay Study and we assist with the R&D process, research strategy, planning, study design, equipment, protocol writing, randomization scheme generations, biostatistics, report writing and over all submissions.
In India we have a dedicated team who only focuses on the local regulatory requirement which need to be fulfilled before clinical study is initiated.
The responsibilities include:
- Based on the experience, recommend to the sponsor whether to apply for BENOC/T-Licence on need bases.
- The team handles application for BENOC/T-License for sample shipment, query resolution, approval to Gwalior for Psychotropic substances.
- Review and completion of required documentation for application to local regulatory to ensure appropriate study related approvals are in place in a timely manner.
- Track the progress of all relevant local regulatory approval(s) in coordination with project management team.
- Efficiently work with the project management team plus keep the team updated about the approval to ensure that all the required local regulatory approvals are placed and complied with the need.
- Set up meetings with DCGI officials for any query resolution
- The department is responsible for preparation of customize study report meeting sponsor’s requirements as well as requirements of regional guidelines of the following regulatory agencies.
- US Food and Drug Administration (FDA)
- Therapeutic Products Directorate (Health Canada)
- European Medicines Agency (EMA)
- International Conference on Harmonisation (ICH)
- Therapeutic Goods Administration (TGA)
- World Health Organisation (WHO)
- Studies conducted over the years have been reviewed and approved by major authorities, and have been successfully audited by the following agencies:
- US Food and Drug Administration (FDA)
- World Health Organisation (WHO)
- Medicines and Healthcare products Regulatory Agency (MHRA) United Kingdom
- Agencenationale de sécurité du médicament et des produits de santé (ANSM) (France)
- Austrian Agency for Health and Food Safety (AGES) (Austria)
- Agencia Española de Medicamentosy ProductosSanitarios (AEMPS) (Spain)
- Medicines Control Council (MCC) (South Africa)
- Department of Medical Sciences, Ministry of Public Health (Thailand)
- Turkish Medicines & Medical Devices Agency, Ministry of Health (Turkey)
Cliantha’s team of very experienced and highly trained medical writers are responsible for preparing the study protocols in line with the sponsor’s requirements and applicable regulatory guidance. The medical writing team also coordinates with the ethics committee for the necessary approvals
- Protocol development
- Protocol amendments
- Informed Consent Forms
- Case Report Form preparation
- Clinical study reports
- Bioanalytical sample analysis reports
- Method validation report
- Incurred sample re-analysis (ISR)
- Pharmacokinetic reports
- Biostatistical reports
- Final comprehensive report including safety reports
- Various types of documents necessary for a successful clinical trial
Our medical writing services are in full compliance with applicable regulatory requirements.
Scientific Equipment and Specialized staff
Bio-Instrumentation equipment & techniques
- Transepidermal Water Loss (TEWL) – DermaLab, DermaLab Combo, VapoMeter
- Moisturization – Corneometer, Skicon, NovaMeter
- Viscoelasticity – Cutometer
- Skin color – Chroma Meter CR-300 and CR-400
- Sebum production – Sebumeter& SEBUTAPE® Skin Indicators
- Skin pH – pH Meter
- Exfoliation & dryness – D-SQUAME® Skin Sampling Discs
- Tape stripping
- Wound creation via dermal abrasions and chemical insult
- Wrinkles and skin texture – Silicone Replica Image Analysis
- Anti-aging – Physician assessments and trained evaluators
- Solar simulators
- Canfield VISIA-CR
- Canfield Canon PowerShot G12 Clinical-Grade Digital Camera
- Canfield Sterotactic Facial Positioning devices
- Faraghan Medical Camera Systems – Portable digital UV camera
- Macro Photography, Cross & Parallel-Polarized Lighting
- Refrigerated centrifuges
- Skin irritation
- Cold sores
Subject Recruitment/ Screening
Cliantha has dedicated teams at Ahmedabad, Vadodara and Saint Petersburg locations responsible to ensure that sufficient number of subjects are meet the complex requirements of each protocol.
Below are some of the highlights of our India recruitment teams:
- We recruit from a subject database of 55,000 subjects that includes healthy adult male / female, postmenopausal females, elderly males.
- Sponsors have access to a large and diverse subject pool.
- We utilize “Online Volunteers Information System” (OVIS), a comprehensive database across Gujarat to track participation status and histories. Through this system, we can avoid cross study participation.
- We have an in-house database named Clienthix Volunteer Data Management System (CVDMS) a central database to track enrolment, screening, participation status and histories, including demographic and medical information.
- Prospective subjects undergo a pre-study interview, complete medical history, physical examination, collection of study demographics, ECG recording and vital signs as required.
- Prospective subjects undergo an informed consent process, during which they are informed of their rights and safety and potential risks in the study if any.
- Prospective subjects are tested for pregnancy, drugs of abuse and alcohol for assessment of study eligibility based on the protocol requirements
- Cliantha has dedicated Clinical Labs to analyse the samples we have received from our screening team.
US recruitment team highlights:
- Our recruitment department recruits from a subject database of over 33,000 potential volunteers that include
- Normal healthy adult male & female bioavailability/bioequivalent studies
- Healthy subjects with various Fitzpatrick skin types
- Special populations i.e. postmenopausal females, geriatric males and females, infants/pediatric, hypo-gonadal males, actinic keratosis, acne, eczema, atopic dermatitis, renal impaired, hepatic impaired, hypertensive, and diabetic subjects
- The recruitment department has the capability to run feasibilities requests with a multi-disciplinary approach from medical, clinical capabilities, logistical, and utilizes our project management software.
- Our sites utilize certified Spanish translated documents which are approved by the IRB to expand the population pool/database. Our site is fully staffed with bilingual staff to expedite the recruitment and study procedure process.
- HTR uses some of the following methods for recruitment:
- Outbound calls from our continuously growing database
- Community Outreach, fairs, festivals, and other local events,
- Social Media ads ie Facebook and Instagram
- Generic Advertisements in order to have subjects ready for immediate study placement (Building Advertising, newspaper ads), Flea markets, Festivals, Schools, Job Fairs, Churches, etc.
- Live recruitment with field involvement
- Advertisements on Buses and mass public transportation Zip code focused advertising mailers
- Radio and TV advertisements