Neuro-Psychiatry studies are complex and present unique challenges
- Vulnerable patient population with varying degree of compromised decision-making capacity
- Validity of informed consents (probably the most controversial aspect of conducting psychiatry studies)
- Stigma and Taboo in some geographies
- Controlling the placebo response
- No diagnostic laboratory tests for mental illnesses
- Ethical issues pertaining to the risk of deteriorating illness
- Risk of worsening of illness and suicide
- Availability of caregiver and related challenges
- Failed drug screen tests
- Absence of a “hard” diagnostic criteria and reliability of various rating scales
- Social, cultural and regulatory differences
- Availability of sensitive, specific, validated rating instrument in regional languages
- As we have diverse challenges with regional associations, one strategy cannot work for all trials and geographies. CBCC works closely with its team of SMEs and medical advisors to overcome these challenges right from initiation of the protocol development process. We employ various tools for patient recruitment and retention in such trials. The tools range from thorough project customized qualification process, detailed discussion with Principal Investigator, careful drafting of inclusion & exclusion criteria, training of site staff on various aspects such as implementation of rating scales, etc.
Our capabilities for quality and timely execution of Neuro-Psychiatry clinical trials
- Team of experienced medical writers, medical monitors and subject matter experts (SMEs) help design robust clinical trial protocols and ensure regulatory compliance, enhanced patient enrollment & retention, and timely completion of the trial with high quality
- Sound understanding and proven regulatory track record with the US, India and other regulatory agencies to help obtain required permissions
- Trained and experienced study team assess feasibility, site qualification, and on-boarding of right sites to complete the study within pre-defined timeline to ensure timely CSR delivery and dossier submission to the regulatory agency
- Skilled study team for site management, tracking patient enrollment and site monitoring
- Robust initial and periodic training of the study team on critical aspects of the study, study procedures, assessments and anticipating safety aspects
- Expert data management, biostatistics, and report writing team ensure timely delivery of regulatory-compliant study reports
Dr. Jonathan McKinnon, CBCC SME - USA
- Dr. McKinnon earned his M.D. from the Ohio State University. He then completed his residency in neurology, and fellowship in clinical neurophysiology from the Mayo Clinic, Arizona. He earned another fellowship in clinical neuromuscular medicine from the University of California, Irvine. Dr. McKinnon is the founder of the Las Vegas Clinic, a center of excellence for diagnosis and management of neurological disorders. His practice focuses on evaluating and managing disorders involving the peripheral nerve and muscle, and he helps bring a comprehensive approach in neurology and the neuromuscular space. Dr. McKinnon is a board-certified neurologist with a specialty board certification in neuromuscular medicine.
Dr. Parth Goyal, CBCC SME - INDIA
- Dr. Parth Goyal has completed his M.B.B.S. from Bharati Vidhyapeeth Deemed University Medical College, India and M.D. (Psychiatry) in 2017, from Sumandeep Vidyapeeth University, Vadodara. He completed 3 years of residency training in Psychiatry, at the Department of Psychiatry, Smt B.K. Shah Medical College and Research Centre, Sumandeep Vidyapeeth. He was a Research Associate at Yale School of Medicine, Department of Psychiatry, U.S.A. (2014) where he worked on Repetitive Transcranial Magnetic Stimulation, and its role in the reduction of Auditory Hallucination in treatment-resistant schizophrenia under the guidance of Dr. Ralph Hoffman. He also completed his clinical rotation (1 month) in ‘in-patient services’ at Yale Psychiatric Hospital, Yale University under the supervision of Dr. Robert Ostroff. He has achieved a clinical attachment with the National Health Scheme (United Kingdom) under the guidance of Dr. A. N. Chowdhary. He was also selected as an associate student member to the International Academy of Behavioral Medicine, Counseling, Psychotherapy and Chemical Dependence, Texas, as an associate student member. Dr. Goyal is a consultant psychiatrist at Parth Hospital and CIMS Hospital.
- We follow stringent criteria in selecting our study sites to generate high-quality data within competitive timelines
- CBCC has established excellent relationships with experienced clinical centers in the US and India
- We have >100 clinical trial sites for Neuro-Psychiatry in our databases, and site investigators and staff are trained in current regulatory requirements along with experience in multiple indications
- We have a network of >60 sites in India and >40 sites in the US
- We can support patient enrollment in China, Australia, and European countries through partners
- We have premium site network with prior experience in successful regulatory inspections
CBCC's experience on Neuro-Psychiatry clinical trials
- Irrespective of your focus area and trial requirements (both, simple and complex trial), our team can support end-to-end clinical trial execution of your trials.
- Few areas, in which our team has supported leading pharmaceutical and biotech companies for Neuro-Psychiatry drug development including regulatory services, Phase I/II/III and PK studies, are:
- We are experienced in designing and execution of both, early and late phase Neuro-Psychiatry trials. Our team helps various pharmaceutical, biotech, and medical device companies accelerate advancement of novel therapies through clinical testing. Medical writers, regulatory experts, clinicians, SMEs, statisticians, data management and clinical operations experts helps you in achieving your organizational goals of delivering high quality and efficient therapies for patient care.
At CBCC, we support Neuro-Psychiatry drug development in multiple ways
- Early phase trials
Pharmacokinetic and safety studies in healthy subjects when scientifically and medically justified
Pharmacokinetic and safety studies in patients wherever study in healthy subjects is not scientifically and medically justified
Pharmacokinetic studies for ANDA and MAA
Other early phase clinical studies like QT/QTc studies, DDI studies, SAD/MAD studies etc.
Proof of concept studies
Early safety and efficacy studies
- Late phase trials
Therapeutic confirmatory trials
Phase 4 trials
CBCC’s value addition to your Neuro-Psychiatry drug development
- We are well-placed to support all your clinical development programs for both, simple and complex indications.
- We can support you to:
Design scientifically sound, regulatory compliant and medically corroborating clinical trial programs for NCEs, 505(b)(2)s and ANDA submissions
Get easy access to KOLs for drafting robust protocols and clinical development plans
Manage projects and facilitate all regulatory activities including USFDA communications
Select right sites with high patient pool to expedite patient enrollment
Manage multi-country patient enrollment from site selection to close-out
Generate high quality data at sites through optimum monitoring plans
Ensure continuous support during post-study regulatory inspections