This document discusses key considerations for clinical site selection and activation. It notes that site selection, start-up, and patient recruitment are critical factors that can compress or delay clinical trial timelines, which impacts costs and market opportunities. Delays of just one day can equate to $100,000-$200,000 in operational costs or $2-5 million in lost sales revenue. The document provides criteria for selecting sites that have experience in indications, are strong recruiters, and can rapidly negotiate contracts and activate trials. It also discusses steps sites can take to efficiently prepare and qualify for trials to achieve fast startup.
New data spotlight value of Train + Test approach to close dangerous regulatory knowledge gaps.
Expert presents 3-point plan to enhance compliance education (Slide 49 and 55)
David cocker feasibility_and_web_miningDavid Cocker
Feasibility studies aim to objectively and rationally uncover the strengths and weaknesses of existing resources required to carry through, and ultimately predict the prospects for success
Can software do the hard work for you.
New data spotlight value of Train + Test approach to close dangerous regulatory knowledge gaps.
Expert presents 3-point plan to enhance compliance education (Slide 49 and 55)
David cocker feasibility_and_web_miningDavid Cocker
Feasibility studies aim to objectively and rationally uncover the strengths and weaknesses of existing resources required to carry through, and ultimately predict the prospects for success
Can software do the hard work for you.
Developing High-Impact Communication Forms to Brief Senior Leaders: Optimizin...Best Practices
Competitive Assessments and Clinical Landscape Assessments are crucial to the success of new products in the pharmaceutical industry. In order to inform busy executives quickly and effectively, market intelligence and analytics leaders must develop briefing templates that are clear, concise, and impactful.
This study identifies winning strategies for effectively informing senior leaders through Competitive Landscape Summaries and Clinical Development Profile Maps. The research will help executives to understand what the important elements to include are, and what are the best formats for two critical healthcare briefing templates: : 1) the Competitive Landscape Summary Map and 2) the Development Landscape Profile Map (often described as the Data Disclosure or Clinical Trials Progress Summary).
Read more at: http://www.best-in-class.com/bestp/domrep.nsf/products/developing-high-impact-communication-forms-to-brief-senior-leaders-optimizing-competitive-assessment-data-disclosure-summaries?OpenDocument
Highlights From 7th Medical Science Liaison/MSL ConferenceExL Pharma
Current trends, issues and challenges facing MSL's in the pharmaceutical industry. Presented at the 7th MSL Best Practices conference, April, 2010. For further information, please visit www.exlpharma.com
One of the largest challenges in the physician relations function is keeping up with physician relationship management. Some have turned to standard CRM/PRM programs with limited success. The key reason – current systems aren’t designed to accommodate the unique strategies required for outreach. Leveraging best practices in physician relationship management, we’ve designed Physician360. This white paper examines how this solution can address the most pressing needs of physician relations functions.
The current healthcare environment necessitates customer insight as a foundation for effective planning. However, constraints of budget, resources, and time can dissuade leaders from developing proper insights. That’s a huge mistake…
Though traditional methods of understanding customer needs continue to be valuable today, they are not the only option available. Based on your specific objective, this white paper provides you with tools that vary in cost, resource requirements, application, and sphere of action.
Make money with big data by organizing your company around your customers. I presented this deck at the Cybera Big Data #cybersummit 2012 in Banff, Canada. In it, I talk about customer loyalty, how to use driver and linkage analysis to sort out both what's important to your customers and what will drive sustainable revenue for your business. Case studies include a SaaS software company, and U.S. Hospital patient experience data based on HCAHPS patient surveys from 4,610 health care facilities nationwide.
You never get a second chance to make a first impression.Endeavor Management
The contact center is the first step in the ideal experience for patients and physicians. In this brief presentation, Gelb will illustrate best practices in contact centers created by national leaders in healthcare. We will examine the differences between functional needs (what must be done) and emotional needs (how patients and physicians feel about your contact center). How does your contact center rate on the 9 Dimensions of call center strategy? Does your contact center engage and enchant callers?
Developing High-Impact Communication Forms to Brief Senior Leaders: Optimizin...Best Practices
Competitive Assessments and Clinical Landscape Assessments are crucial to the success of new products in the pharmaceutical industry. In order to inform busy executives quickly and effectively, market intelligence and analytics leaders must develop briefing templates that are clear, concise, and impactful.
This study identifies winning strategies for effectively informing senior leaders through Competitive Landscape Summaries and Clinical Development Profile Maps. The research will help executives to understand what the important elements to include are, and what are the best formats for two critical healthcare briefing templates: : 1) the Competitive Landscape Summary Map and 2) the Development Landscape Profile Map (often described as the Data Disclosure or Clinical Trials Progress Summary).
Read more at: http://www.best-in-class.com/bestp/domrep.nsf/products/developing-high-impact-communication-forms-to-brief-senior-leaders-optimizing-competitive-assessment-data-disclosure-summaries?OpenDocument
Highlights From 7th Medical Science Liaison/MSL ConferenceExL Pharma
Current trends, issues and challenges facing MSL's in the pharmaceutical industry. Presented at the 7th MSL Best Practices conference, April, 2010. For further information, please visit www.exlpharma.com
One of the largest challenges in the physician relations function is keeping up with physician relationship management. Some have turned to standard CRM/PRM programs with limited success. The key reason – current systems aren’t designed to accommodate the unique strategies required for outreach. Leveraging best practices in physician relationship management, we’ve designed Physician360. This white paper examines how this solution can address the most pressing needs of physician relations functions.
The current healthcare environment necessitates customer insight as a foundation for effective planning. However, constraints of budget, resources, and time can dissuade leaders from developing proper insights. That’s a huge mistake…
Though traditional methods of understanding customer needs continue to be valuable today, they are not the only option available. Based on your specific objective, this white paper provides you with tools that vary in cost, resource requirements, application, and sphere of action.
Make money with big data by organizing your company around your customers. I presented this deck at the Cybera Big Data #cybersummit 2012 in Banff, Canada. In it, I talk about customer loyalty, how to use driver and linkage analysis to sort out both what's important to your customers and what will drive sustainable revenue for your business. Case studies include a SaaS software company, and U.S. Hospital patient experience data based on HCAHPS patient surveys from 4,610 health care facilities nationwide.
You never get a second chance to make a first impression.Endeavor Management
The contact center is the first step in the ideal experience for patients and physicians. In this brief presentation, Gelb will illustrate best practices in contact centers created by national leaders in healthcare. We will examine the differences between functional needs (what must be done) and emotional needs (how patients and physicians feel about your contact center). How does your contact center rate on the 9 Dimensions of call center strategy? Does your contact center engage and enchant callers?
An introduction to data centers, including a discussion on location criteria, key factors to look for when thinking about establishing a data center in an existing building and case studies on data centers in the Atlanta and Toronto areas.
A zero-energy building, also known as a zero net energy (ZNE) building, net-zero energy building (NZEB), or net zero building, is a building with zero net energy consumption, meaning the total amount of energy used by the building on an annual basis is roughly equal to the amount of renewable energy created on the site,or in other definitions by renewable energy sources elsewhere.These buildings consequently contribute less overall greenhouse gas to the atmosphere than similar non-ZNE buildings. They do at times consume non-renewable energy and produce greenhouse gases, but at other times reduce energy consumption and greenhouse gas production elsewhere by the same amount.
Shanghai Supertek Lighting Co.,Ltd.(Supetek). Our company website is: www.Supertek.cc have been lighting business for more than 20 years and in induction business for more than 5 years. Our products are UL ,ETL and CE certified and currently 90% of our products are exported to the U.S and European market.Now we are one of the most professional manufacturer of induction lamps and high wattage HID electronic ballast.(600-1500W)
EPiServer AB es una empresa multinacional especializada en ofrecer soluciones para la gestión eficiente de contenidos web, Web Content Management (WCM), apareciendo en el Magic Quadrant de Gartner para WCM como “ visionaria”.
Tricks of the trade: Turn Around Your Slow-Enrolling TrialImperial CRS
Common factors behind slow enrollment
Creating a plan of attack
Setting realistic expectations
Getting management on board
Energizing sites and other stakeholders
Execution and performance tracking
Leverage Big Data Analytics to Enhance Clinical Trials from Planning to Execu...Saama
Nikhil Gopinath, Senior Solutions Engineer for the Life Sciences at Saama, spoke at EyeforPharma's Clinical Trial Innovation Summit event in February 2017. These slides are from his "Leverage Big Data Analytics to Enhance Clinical Trials from Planning to Execution" presentation.
Slideshow presentation for a proposal to implementation an EHR solution in a small hospital. Presented in conjunction with Gannt Chart and project plan.
Customerlogo hereProject Name Project CharterCompanyOllieShoresna
Customer
logo here
Project Name: Project Charter
Company
logo here
Project Name:
Value Driven Project and Portfolio Management in the Pharmaceutical Industry
Project Charter
Project:
Value Driven Project and Portfolio Management in the Pharmaceutical Industry
Title:
Project Charter
Document number:
Version
0.1
Document status:
Final
Author:
Chellyn Jones
Responsible:
Date created:
14/08/2021
Protection class:
"For internal use only"
Document history
Version
Date
Author
Comment/Change
0.1
10/08/2021
Draft
14/08/2021
Final
Page
1Background/Project purpose or justification4
2Goals5
2.1Goals
2.2Scheduling goals/milestones
3Project product description6
4Delivery units7
4.1Delivery units/services
5Project success criteria8
6High-level risks9
7Key stakeholders10
8Assumptions, restrictions and external dependencies11
9Responsibility of the customer12
9.1Tasks
9.2Resources and staffing
10Project category13
11Project budget (overview)14
12Project startup15
13Project end16
13.1Signatures for release
Annex17
A.Glossary and abbreviations17
B.References, accompanying documents
1.
Background/Project Purpose or Justification
Pharmaceuticals' perspective has shifted as a result of the rising healthcare expenses that are currently affecting everyone, and pharmaceuticals are focusing on the generation of value in research and development. Value-driven portfolio management is a term that has long been associated with the financial sector but has recently gained popularity in the pharmaceutical industry. The notion of value-driven portfolio management focuses on connecting a company's strategic goals and objectives with resource allocation. A corporation can raise the value of pharmaceuticals while also lowering healthcare expenses by focusing on studying the risks and effects.
The project's purpose is to create a value-driven project for the pharmaceutical company by following a set of decision-making stages. The steps will include developing a targeted product profile, defining a timeframe, developing a budget that is consistent with the goal product profile, and ultimately developing a stage gate decision-making system.
2. Goals
This section addresses the goals of the project which indicate what the project intends to achieve and the milestones related to the goals established.
a. Goals
Goal
Description
Efficiency
Efficiency in the drug development process will mean that pharmaceuticals develop drugs through maximum utilization of the resources and ensuring that the waste products from the process are as minimal as possible.
Strategic alignment
The goal is to come up with projects that are aligned with financial and strategic goals of pharmaceuticals.
b. Scheduling Goals/Milestones
Schedule
Description
Phase 1
· Defining the scope and the budgets for the projects
· Developing the goals of the project.
· Evaluation of the potential risks
Phase 2
· Coming up with the key performance indicators
· Tracking per ...
Global Clinical Trials: Best Practices & Common PitfallsImperial CRS
45% of clinical trials are conducted exclusively in non-U.S. countries, and only 6% are registered in both the U.S. and rest of the world. The globalization of clinical trials demands deeper knowledge and greater efficiencies in planning and execution. In our inaugural webinar, Melynda Geurts, Dan McDonald, and Gwen Welty of DAC Patient Recruitment Services explore actionable solutions to real-world multinational trial challenges, including:
Protocol Design
Regulatory Planning
Local Expertise and Logistics
Study Feasibility
Investigator Relations
Recruitment and Retention
FOR MORE INFORMATION, VISIT WWW.IMPERIALCRS.COM
ISPE guidelines - checklist for Project Managers to submit the Business case and feasibility. Really useful.
Mainly for the construction of Pharmaceutical facility, one must try to furnish these information before getting ahead
How to evaluate scientific grant review proposalsPubrica
The grant proposal review process allows sponsors and organisations to put their stated ideas into action. However, determining which grant writing services to support in order to achieve mission-driven goals is a difficult effort that begins with learning how to correctly and swiftly analyse a grant proposal services request.
Continue Reading: https://bit.ly/3c3cu5m
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2nd Annual Clinical Site Feasibility, Selection, and Startup, March 2011, Phi...ExL Pharma
Optimizing Trial Performance and Reducing Pharmaceutical Costs Through Effective Identification and Activation of Sites and Enhancing Stakeholder Communication
3. Clinical Development Program Background Program/Project and Protocol Timelines Impact to Program/Project Cost and Timelines Marketing Considerations – Opportunities Criteria for Selection Sponsor/CRO Considerations Site/SMO Considerations Academia Considerations Site Selection Criteria Topics
4. Clinical Development from IND to NDA 250 to 500 million USD to complete clinical 5 to 7 years timeline for clinical Equates to: 35.25 to 71.5 million USD per year to run clinical 100K to 200K per day during clinical development Development Key Points
5. $$- TIME IS MONEY -$$ Every day the trial is operating is 100 to 200k USD operational cost. Development Key Points
6. Marketing Considerations and Opportunities Blockbuster drug can generate 2-5 million USD per day in sales revenue Windows for marketing a drug are dynamic First to market wins market share Claritin OTC versus Zyrtec OTC example Market share decreases dramatically based on tier approval; First in Class, First to Market, 2nd to Market etc. Development Key Points
7. $$- TIME IS MONEY -$$ Delays in Time to Market 2 to 5 million per day 700 to 1,500 million per year Decreases in market share from 75/80% to 25% Development Key Points
8. Corporate Fiscal Management Budgets are developed for 3-5 year plans Forecasts are performed yearly and quarterly Development program budgets span across almost a decade Shifting funding from one year or quarter may mean raiding funds for other clinical programs, acquisitions, mergers, bonuses, pay increases, etc. Executive management take very seriously delays that impact corporate investor relations and solvency Development Key Points
9. Impact of Clinical Development Program Delays Delays impact traditional development models, employees, stakeholders, investors, and the public. Paradigm shifts: Many companies are outsourcing clinical programs to CROs and Clinical Service Providers. Mergers/Acquisitions: Many companies are undergoing mergers to consolidate costs and create synergies. Layoffs: Companies are more often cutting back on employee debt load to conserve finances for development and solvency. Development Key Points
10. $$- TIME IS MONEY -$$ Operational Costs Marketing and Market Opportunity Costs Corporation Cash Flow and Solvency Mergers, Layoffs, and Paradigm Shifts Development Key Points
11. Clinical Development Program Timelines Clinical endpoints set by FDA, EMEA, and other CAs. Treatment duration defined by endpoints selected. These factors are not dynamic and dictate length of program, project, and protocol duration. Dynamic influencers are study start up, length of recruitment, data cleaning, data analysis, NDA package assembly, and NDA submission. Study start-up and recruitment are low hanging fruit for timeline compression – also areas for dramatic delays. Development Key Points
12. Timeline Compression or Delay Study Start-up is critical to program timelines. Site Selection. Site budget/contract negotiations. Site approval and activation. First patient in (FPI). Patient recruitment period is critical to timelines. Last patient in (LPI). Last patient out (LPO). Timelines
13.
14. Site Selection is critical to timelines Rapid contract and budget negotiations. Rapid site IRB approvals. Rapid site activation. Hard hitting recruitment. Rapid FPI All equate to a shortened program timeline OR Significant study delays = program delays Timelines
15. $$- TIME IS MONEY -$$ Shortening study start up by one day = 100-200K operational costs. = 2-5 million marketing or sales revenue. Delays result in similar losses Timelines = Costs
16. Sites previously used by sponsor speed processes. Sites that have standardized contracts/budgets. Eliminates multi-pass review with Legal and Finance. Accurate program per patient cost projections. Sites that rapidly negotiate contracts/budgets. Sites that can use central IRBs or have rapid locals. Study Site Selection Criteria
17. Sites with that know/experienced with disease indication. Sites that are experienced in clinical research. Sites that are known to be hard hitting recruiters. Sites with internal study marketing personnel. Sites that have large PT DBs. Study Site Selection Criteria
18. Negotiate MSAs with centers used often – especially acadaemia. Use sites with Hx of rapid negotiations, activation, and FPI, and LPI. Limit number of KOL/academic centers – slow to start and low numbers. Using centers often has benefit of no or short PSV. Sponsor/CRO Considerations
19. Use sites that are hungry for trials, call often, respond rapidly, provide marketing material. Maintain DB of sites with solid performance metrics, share across TAs, update often. Contract CRAs know the good centers – listen to them. Sponsor/CRO Considerations
20. Maintain internal performance metrics and hold staff accountable. Have accurate and concise study site marketing materials Hx performance metrics, Breakdown of disease specific Pt DB information, List networks with local referring Docs/practices/centers. Gain exemptions to use central IRBs if using a local. Develop and maintain standardized budgets and contracts. Site/SMO Considerations
21. Develop and maintain standardized “pull-n-send”regulatory packets for rapid submission. Keep pt DB up to date – build and maintain relationship with clinic and research patients, communicate often via newsletters, mailings, etc. Train or hire marketing coordinator for study promotion. Site/SMO Considerations
22. Develop and maintain great relationships with Legal, Grants/Contracts, IT, IP, and local IRBs. Work to educate and inform above that centers must have rapid turn around times for Sponsored trials. Obtain local IRB exemptions if at all possible. Academia Considerations
23. Develop and maintain referral partners within center, town, region, state; communicate often. Be responsive to Sponsor/CROs; return calls and emails immediately, regardless of status changes. Develop execution/action oriented attitude within staff and academic center – must have “can-do” attitude to capture sponsored trials. Put out “fires” immediately – if Sponsor appears frustrated, they are!! Academia Considerations
24. SITE PERSPECTIVE:An In-depth Look at What Drives Site Decisions and Strategies for Putting Sites in Position for Success
25. Inaccurate Feasibility Questionnaires Unrealistic enrollment expectations Inaccurate enrollment time lines Research Staff Lacking Training and Experience Inexperienced PIs Not Reading the Protocol in its Entirety Lack of knowing study related procedures Missed details of inclusion and exclusion criteria 25 Initial Practices that Hamper Site Success
26. CTA Review Budget Negotiation IRB Submission/Approval ID of Sub-Contracting Required EDC Training Scheduling Conflicts with Site Initiation Visit 26 Common Reasons for Delays in Site Activation
27. 27 Factors Most Often Causing Study Delays Source: CenterWatch Survey of Investigative Sites in the U.S.: 2009 (n=950)
29. Internal Preparation Practices: Unique feasibility assessment PI training/qualification Access to facilities for specific procedures Lasting first impressions for site selection visits Budget development tool Streamlined site activation 29 Steps to Effectively Prepare for Site Success
30. 30 Achieve Fast Site Activation Improve Efficiency Within Timelines
31. Time Is of The Essence Budgets & Agreements: Regulatory submissions: Preparing IRB submissions Know what’s required (signatures, ads, etc.) Legal review of agreements/ICF Simultaneous budget negotiation 31
32. Compliance Educate often and be current on new policies for State and National coverage in Clinical Trials Systematic Tracking of Enrollment & Revenue Use study management software to: Track subject enrollment and study visits Better revenue collections Maintain secure subject data Track study milestones and payables 32 In Addition…