Clinical Research Organization (cro)
**please respond to the following request with a proposal if:
1) you currently, or within the last year, work at a pharmaceutical or biotech firm.
2) you are familiar with phase 1 clinical trials.
Familiarity with and understanding of how biopharma and pharmaceutical companies decide which cros to use for early stage phase 1 clinical research. Will be able to speak to growth trends related to spending on r&d in industry and spending on cro services. To the extent possible, will be able to speak to how this may differ for innovator versus generic drugs. Will be able to speak to the reputations of different cro service providers for early stage phase 1.
1) how has your spending on cro early stage services trended in the past few years? What is your outlook for demand for cro services? Why? To the extent you can speak to this, how has this differed for generic vs. Innovator drugs?
2) what is the decision process for determining which early stage phase 1 cro to use?
3) what factors are considered when determining which early stage phase 1 cro to use?
4) what are the early stage phase 1 cros that come to mind? Which cros have you considered? How do cro reputations differ across the different stages of clinical research (early vs. Late)? For different clinical services?
5) what are the trends for early stage phase 1 cro services moving overseas?
Areas of expertise:
seeking experts with knowledge of clinical trials, phase 1-4; clinical trials; early clinical research; cro; early stage clinical research; cros; clinical research organization; clinical research
+7 Other ResponsesClinical Trial
This is a full-time employment opportunity for a clinical trial manager (ctm) in the san francisco area.
-responsible for coordinating and monitoring the day-to-day logistics of our clinical trials.
Functions:
-manage clinical trial operations including vendor performance, internal/external metrics, and communication of project status within the project team
-manage and track completion of study start-up, conduct, and closeout activities to industry and corporate standards
-ensure the progress and completion of projects according to timelines
-prepare and present project specific updates
-lead or assist in the writing of clinical documents such as protocols, study reports, study manuals, and annual reports
-monitor safety surveillance and reporting activities
-oversee data management processes including collection and cleaning of clinical database, reconciliation of clinical and safety databases, and data interpretation and evaluation
-coordinate dsmb/safety reviews inline with charter and overall study parameters
-assist in the construction of clinical development processes including development and writing of sops, creation and organization of study trial master files, and clarification of organization and workflow structures
-plan, generate, and track study timelines and trial budgets
-site management activities including: review monitoring reports, interact with study monitors, track site errors or other indicators of site difficulties, identification of potential problem sites and development of corrective action plans as required, acting as our contact, as needed, for clinical sites
experience:
-ba/bs degree in biological science or nursing required (equivalent experience may be accepted)
-5+ years of clinical research in the biotechnology/pharmaceutical industry
-3+ years of multi-center clinical trial management experience, specifically experience in phase 2, phase 3 us & international clinical trials
-experience managing cros, central laboratories, and other clinical study vendors
-experience preparing clinical trial budgets and contracts
-knowledge of ich-gcps and 21 cfr is required
-experience in metabolic/hepatic drug development is desirable
-experience with ivrs and/or edc is desirable
+24 Other ResponsesClinical Trials
Clinical trials, regulatory approvals' timelines and clinical research organizations in south africa
+17 Other ResponsesClinical Research Organization
Hello,
we are a prominent nyc-based expert network and an authorized zintro partner
our client has an immediate need to conduct phone consults with multiple experts knowledgeable about contract / clinical research organization (cro) industry. More specifically, they are hoping to better understand the overall market growth, trends & outlook, as well as key segments.
Here's more information on the type of people they are looking to speak with:
• a cross-section of pharma and biotech players of different sizes
o expert must have ownership of development pipeline
o have expertise related to key large/growing tas (therapeutic areas) and regions – initial hypothesis is focused on oncology, infectious diseases/vaccines, immunology
o we would probably like to speak to mostly us players, some european and a couple in asia
• sponsor members who own (or influence) outsourcing decisions (e.G., operations, clinical research)
• cro members responsible for strategy/planning and pricing decisions
• potentially across other segments of the value chain
thanks,
tj
+19 Other ResponsesCro Outsourcing In Clinical Trial
We are a market research company looking for the following information pertaining to cros on behalf of our client:
unique cro outsourcing trends in the clinical trial (cro) industry where cros have been innovative in how they offer services to pharmaceutical companies; real life examples between cros and pharmaceutical companies
preferred or approved supplier for major pharmaceutical companies
how other pharmaceutical companies validate cro rates without going out to bid?
Supplier analysis and market analysis
+24 Other ResponsesClinical 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 ResponsesClinical Trials Management
This is a 12 month contract opportunity in california: clinical trial manager/sr ctm - asthma
overview:
responsible for managing the full scope of proper study conduct including, but not limited too, protocol development to final report, regulatory filing and/or publications, coordinating cross functional efforts in the administration and progress of phase 1 to 4 clinical trials. Additional responsibilities include trial start-up, conduct, and close-out activities in order to achieve program objectives and goals.
The incumbent will use professional concepts in accordance with company objectives to solve complex problems in creative and effective ways. May determine methods and procedures on new assignments. Works on complex problems in which analysis of situations or data requires an in-depth evaluation of various factors. Exercises judgment within broadly defined practices and policies in selecting methods, techniques and evaluation criteria for obtaining results.
Responsibilities:
-lead clinical trial project execution for asthma programs to ensure that trial timelines, costs, and quality metrics are met.
-serves as primary contact for functional area representatives in managing protocol execution.
-manage the financial aspect of clinical trials to ensure accuracy and timeliness of service provider and site payments.
-forecast and oversee clinical supplies, e.G. Study drug.
-manage study milestones to ensure accurate tracking and reporting of study metrics.
-oversee ongoing service provider management (e.G., cros, ivrs, central labs), including independent negotiation of scope of work, budgets, performance management, and issue resolution.
-create and manage clinical trial budgets in collaboration with manager and the vice president of clinical operations.
-may provide study-specific direction and mentoring to cras and ctas.
-collaborate with clinical quality assurance to maintain quality standards in compliance with regulatory requirements/guidance’s and adherence to sops and ich/gcps; participate in ongoing process improvement initiatives.
-manage adherence to ich/gcp/local regulations.
-participate in clinical operations initiatives and programs.
Qualifications:
-bachelor’s degree with at least 5 to 8 years of cra experience for the manager level with at least 1 year of staff management experience. The senior manager level requires 10+ years of combined cra and ctm experience and 3 years direct staff management experience is required.
-experience in inflammatory diseases, specifically asthma and/or chronic obstructive pulmonary disease (copd) is required.
-experience developing trial plans including developing creative strategies for site monitoring, risk mitigation, trial budgets, site selection, and clinical supplies management.
-extensive clinical research knowledge and cross-functional understanding of clinical trial methodology.
-team oriented and collaborates effectively with the clinical operations study team, cross-functional team members, and external partners.
-working knowledge of ms project for development and update of clinical study timelines.
Contact us here on zintro for further details.
+17 Other ResponsesOutsourcing Clinical Research
Looking for subject matter experts / consultants in clinical research, clinical trial, risk management, audit and inspection, gcp .Feel free to reach out to me.
+46 Other ResponsesClinical Research
Looking for subject matter experts / consultants in clinical research, clinical trial, risk management, audit and inspection, gcp, clinical outsourcing, trial design and management,ethics fraud and misconduct, patient recruitment , documentation and management, clinical laboratories, facility/hospital , hospital clinical compliance, billing and coding for clinical services , patient/third-party coding and billing, sponsors, cros, clinical quality control/cqc for speaking engagements with over 25+ years of experience. Feel free to reach out to me.
+20 Other ResponsesPhase Iv Clinical Trial
I would like to discuss about phase iv clinical trial suppliers in china cro market, about the emerging market strategy, various supply-demand parameters, changes in the cro market in china, past history about merger and acquisition in china cro market, best practices being followed in phase iv trials.
+6 Other ResponsesTherapeutics Clinical Operations
Director, clinical operations. This is a full time employment opportunity in california,usa.
Provide key clinical support for the operation and execution of clinical trials for clinical programs. Ensure compliance and completion of the following clinical drug development activities:
-requires minimal supervision to manage various activities associated with multiple clinical studies
-working knowledge of fda regulations and ich guidelines to ensure compliance with both during clinical trial conduct
-has had experience as clinical operations lead on significant phase i or phase ii programs
-participates in evaluation and selection of cro’s, contractors and other outside vendors, and the development of budgets. Manages cros and vendors, as appropriate
-manages efforts in study start-up, including study feasibility, site selection, preparation and follow-up of site regulatory packages in partnership with the director of oncology clinical development
-independently designs or assists in the development of study related documents including but not limited to: case report forms, case report form completion guidelines, study manuals and project tools, monitoring plans, tracking tools, informed consent forms, and study reports
-may prepare study-specific training materials or slides for investigator meetings
-contributes as part of the clinical protocol development team
requirements:
-ba/bs in science-related field with 10 + years’ experience in clinical operations /trial management or a combination of relevant related work experience
-demonstrated thorough understanding of fda regulations and gcp and proven success record in managing trials
+19 Other ResponsesBusiness Development For Contract/clinical Research Organisation
Looking for an expert to help in business development strategies and tactics for a niche cro (contract/clinical research organisation), specifically as it relates to exploiting scientific expertise and connecting to scientific decision makers in pharma and biotech
+18 Other Responses
