Blinded Clinical Trials
I am looking for an expert who can guide me about the un-blinded monitoring process in blinded clinical trials and help me understand how pharma companies approach un-blinded monitoring. Do they source from a single supplier/multiple suppliers or do they appoint an in-house un-blinded monitor.
Please get in touch asap. This is a little urgent.
Thanks!+11 Other Responses
Early-stage Oncology Clinical Trials
oncology clinical trial managers, organizers, site coordinators, trial investigators/consultants;
oncology clinical trial regulatory personnel; clinical project manager/consultant at cros and pharmaceuticals
priority regions of interest: united states, europe, india
few companies involved in this space: cros conducting early-stage oncology clinical trials (e.G., lambda therapeutic research, labcorp, ppd, iqvia, syneos)
few clients involved in this space: small-to-mid-sized pharmaceutical companies in oncology field (e.G. Novartis, amgen, astrazeneca, bms, biocon, incyte)
the some of the key aspects that we are looking to understand from the experts are (global and india):
o market size and segmentation (value and volume) of oncology clinical trials:
• historic & future growth rate
• market trends/drivers & challenges
• impact of covid-19 on the market demand
o regulatory overview of the indian clinical trial market:
• regulatory submission and approval process
• necessary sops– protocols & guidelines: prerequisites to conduct a clinical trial in india for indian and foreign molecules and medical devices
• mapping of application and approval process: clinical trial commission, trialist and registrant application, necessary documentation required, phase i / ii data review, feedback and institutional ethical committee approval
o assessment of market structure and identification of key cros
• evaluating the market structure for the early- stage oncology trials by the cros and sponsors
• identification of key cros that conduct the early- stage oncology ct globally and in india
• competitive assessment of key cros (lambda research / labcorp / ppd, etc)
• business overview and offerings of the key cros in this space
• information on technologies used for patient recruitment, risk based monitoring, patient monitoring, etc.
• proficiencies in biostatistics and statistical programming, clinical data management
• business model and strategic outlook within the oncology space
• type of customers and services provided
o customer assessment
• identification and segmentation of the key customers (mid – small pharma clients)
• evaluating current and future customer requirement and challenges faced by them+32 Other Responses
Clinical Trial Investigation
I'm looking to talk to clinical trial principal investigators, medical researchers who have run or are running clinical trials, about their experiences.+54 Other Responses
Clinical Research Regulatory Service
• study objective:
to assess the clinical research consulting space with special emphasis on independent review board (irb) services. The aim is to understand the dynamics in the service/product offerings (regulatory compliance, medical writing, strategic affairs, electronic consent manager, meeting scheduler etc.). In addition, we would also like to understand the market overview of irb services comprising of market size, recent trends, drivers, barriers, etc. Focus would be to understand the customer needs, competitive landscape, pricing and market landscape for irb consulting services (regulatory compliance, medical writing, strategic affairs etc.).
• following are some of the key questions:
o what are the different services offered under regulatory consulting in clinical research?
O who are the key users / customers of regulatory consulting services?
O what are the needs for these services of different customers
o what are the factors that influence the customer’s purchase decision of consulting services / products?
O who are the top players providing consulting services and what is their market share?
O what are the billable rates charged on an hourly basis by the companies?
O why, if at all, do the rates differ across various services?
O are there different rates for different customer types? What are the reasons?
O how is the pricing structured for software products such as electronic consent form, meeting scheduler etc.?
o what are the key market trends, growth drivers and barriers to growth etc.?
o where are the key opportunities within the regulatory consulting market?
Preferred expert should meet the following criteria:
o location: us
o industry experience of 15+ years in the clinical research industry
o worked in coordinating clinical trials, device trails and observational studies, regulatory & irb submission, recruitment, data collection and input, source documentation creation, and overseeing good clinical practices (gcp) and ich guidelines
o understanding of clinical studies to ensure compliance with ich/gcp guidelines and federal regulations
o knowledge of regulatory consulting services as well as software offerings specific to clinical trial / research
o understanding of purchase process and pricing structure of consulting services+12 Other Responses