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 Research Organizations (cros)
My firm is doing a diligence project to determine the current growth trends of the market for clinical research organizations (cros). We would also like to understand the effect of the underlying market for r&d drug development and funding for biopharmaceutical companies.
We are hoping to speak to clinical research coordinator, project manager, study coordinators, etc., at pharma and biopharma companies who either focus on innovator or generic drug development. Former or current consultants in this role would be helpful.
Responsibilities of respondent:
familiarity with and understanding of how biopharma and pharmaceutical companies decide which cros to use for early stage 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.
The questions we would like to answer:
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 cro to use?
3) what factors are considered when determining which cro to use?
4) what are the 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 cro services moving overseas?
Please send a line if you are qualified to answer these questions. Thank you.
+12 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 Research Organization (cro)
My firm is looking to speak to an expert in contract/clinical research organizations. Must have knowledge about setup, operations, quality controls marketing, and pr.
+24 Other ResponsesPharma Clinical Research Moderators
We are seeking a highest quality experienced moderator with experience in the life sciences industry - must meet below specifications
moderation location: usa - san fransisco bay area, los angeles, philadelphia, new york, boston.
Industry: pharmaceuticals, contract development and manufacturing organizations (cdmos)/clinical research organizations (cros), and life science market research.
Testing availability: late june - early july
hello, we are conducting market research on outsourcing partnering decisions for a major cdmo/cro. For the qualitative part of the research we are looking for a seasoned moderator with the following specifications to conduct in-person focus group interviews (6-8 pharmaceutical executives who are outsourcing decision makers) at a facility.
1. Minimum 15 years experience with bio-pharmaceutical research and manufacturing, especially contracting with contract development and manufacturing organizations (cdmos) / clinical research organizations (cro) - flexible on years of experience.
2. Minimum 5 years experience with moderating qualitative focus group interviews - flexible on years of experience.
3. Moderating certification required.
4. A clear understanding of the following topics
a. Api services & chemical development – all stages of drug development for small molecules, potent and cytotoxic compounds, and peptides
b. Pharmaceutical development – development cycle of clinical candidate into an optimum formulation and clinical stages manufacturing
c. Analytical services – analytical services supporting drug substance (api) and drug product development including cmc regulatory filings
d. Clinical trial supply – clinical supplies, packaging, distribution and delivery of clinical protocols, supply chain management.
E. Clinical technologies - solutions for patient enrollment, screening randomization, drug assessment etc.
F. Commercial services – api supply, manufacturing, testing and packaging to end-user distribution.
5. Flexibility to travel to facility location.
If you are interested and fulfill the above requirements, please contact us immediately with your profile, a brief summary, rates and confirmation of availability.
+16 Other ResponsesClinical Trials, Phase 1-4
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?
+29 Other ResponsesClinical Trials
**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.
3) ideally, we would like your title to reflect senior outsourcing manager, manager of clinical research (be involved in the decision making process related to cro phase 1 research**
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?
+13 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 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
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 ResponsesClinical Research
We are looking for an expert who can provide us insights on clinical research market in mexico in the following areas:-
* market understanding about the various type of service providers active in mexico (local, regional and global), which is having the majority share by number of trials and by total revenue from the market.
* which type of buyers are mostly active in mexcio market like large pharma, small mid-size pharma, universities or specialized institutions and why?
* the type of clinical trials in mexico done are multi-national, national or regional and how it is aligning with the pharma objective?
* what is the current market size and cagr for the mexico clinical market? Is it still evolving or reached maturity stage , how is the competition among the service providers in mexico market?
* please contact me directly *******@**********.Com or call ************
thank you
sarabjeet
+1 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 Responses
