STRATEGIC RESOURCING. inventivhealthclinical.com

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1 STRATEGIC RESOURCING inventivhealthclinical.com 1

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3 Table of Contents OVERVIEW 02 STAFFING 03 MOVING UP THE VALUE CHAIN 04 FUNCTIONAL EXPERTISE Biostatistics and Statistical Programming 05 Clinical Monitoring 06 Data Management 07 Medical Writing 08 Project Management 09 Global Safety and Pharmacovigilance 10

4 Overview Expert resources for today s CLINICAL development programs. We understand your challenges and offer robust solutions. Today s changing and complex world of drug development means biopharmaceutical companies are looking for innovative ways to accelerate their product pipelines, identify and increase process efficiencies, reduce cost, and improve quality. Now more than ever, you need a strategic partner that offers intelligent global solutions for effectively staffing your programs, managing resources, and optimizing processes. Offering the most experienced team in the industry, inventiv Health Clinical provides expert clinical resources in customized solutions whether you need a single professional or an entire functional team. Experience: Since 1999, our experienced teams have established and maintained more than 30 strategic partnerships with diverse services and configurations. Flexible Continuum of Outsourcing Services Productivity Management Collaborative Process Improvement Staff Lift Out Global Reach: We operate around the world in the Americas, EMEA and throughout Asia Pacific working with both local and global clients. Performance: Our commitment to quality and customer service has ensured long, productive relationships with our partners. Customization: Regardless of size, every resource placement, functional partnership and relationship is designed to meet your needs, processes and approaches. We are committed to meeting the highest level of professional and ethical standards, and are focused on delivering nothing less than the best possible solutions and service. Our standards for quality are high and our aim is for extraordinary results that not only meet but exceed your expectations. Staffing Performance Management STRATEGIC ROI VARIABLE COST RATIO inventiv Health Clinical provides a flexible continuum of services that aligns with your outsourcing strategy. With our innovative approach to customized outsourcing solutions, we are positioned to help our clients improve quality, increase efficiency and manage cost. 2

5 Staffing From a single resource to an entire team, we offer short-term and long-term contracts for a contingent workforce with experience in all phases of development, therapeutic areas, functional services and geographies. We work closely with hiring managers to ensure our candidates match your requirements for every single placement. Our global recruiting engine of more than 130 full time recruiters in over 30 countries is dedicated to strategic resourcing, specializing in clinical research candidate identification and recruiting. We have access to and continuously replenish our worldwide database of more than 200,000 clinical professionals to rapidly fill your positions. inventiv Health Clinical is a Tier 1 supplier for many of the industry s largest third party managed service providers. We have experience working with both open systems and vendor neutral managed service providers. In addition, we can quickly submit first class candidates through the many industry vendor management systems. Flexible resourcing options include: Direct Hire Placement: Work closely with hiring managers to ensure candidates match required experience and culture Contract Staffing: Fully scalable, short-term and long-term resources. We manage their performance and professional development to mitigate co-employment concerns Contract-to-permanent: Introduces you to resources and allows us to train on your systems, policies and procedures. Our process for placement is the best in the business. Applicants undergo a careful screening process which includes education and employment verification. We match the candidate s level of experience and career objectives to our clients requirements in as little as one to two days. Once a candidate has been interviewed and selected, we run background checks required by our clients. We then move to our comprehensive onboarding process to ensure your resources are ready to commence project work within one week of hire. All candidates are provided with orientation and new hire paperwork, including client-specific requirements. We have industry leading retention rates and our candidates work with us again and again. Our satisfaction rate among our sponsors is extremely high % of our contracts are extended beyond their original end date with the same consultants in place. 3

6 Moving Up the Value Chain Our dedicated functional teams have the experience to be your partner in clinical research. With experience in biostatistics, statistical programming, clinical monitoring, data management, medical writing, project management and pharmacovigilance, we deliver clinical development services customized to fit your objectives, whether you need support within a single function, multiple functions within a single therapeutic area or across your entire portfolio. We also have significant expertise in staff lift-outs of clinical development functions to further significantly reduce our clients fixed costs. While you may initially consider just augmenting your existing staff, you should also consider additional services that will unburden your teams, improve productivity and reduce fixed costs. By using our management expertise, it will free your employees from day to day priority setting, progress assessments and resource management. At inventiv Health Clinical, our professional managers will make your job easier by providing a point of contact for all aspects of resource management. Our experienced team leaders have expertise in a wide variety of operational models in most therapeutic areas, software and processes to ensure that clinical studies remain on track. Working closely with each client, our team will determine the right level of service for your specific program. Our resources can be office-based, work remotely or directly onsite at your facility. In all cases we have the flexibility to operate under your SOPs or collaborate to develop new processes. Performance Management: Our team can handle all aspects of day-to-day employee management including onboarding, training, priority setting and workflow management. Our highly experienced team uses industry best practices, while permitting clients to determine the level of management control they want to retain Productivity Management: We can manage resources and productivity and report back metrics and key performance indicators to help identify process inefficiencies and ways to streamline execution within your program. Collaborative Process Improvement: Through shared governance of your program we work closely with your team to analyze existing SOPs, indentify bottlenecks and make recommendations that lead to more efficient processes. Staff Lift Out: By transferring your resources to us, we can dramatically lower your fixed cost. We can assume complete management of your team and focus on delivering the agreed upon outcomes. In this option, our clients have realized cost savings up to 30% compared to an in house approach. If you opt for a strategic partnership, we will gain the added benefits of reduced set-up and administrative costs that are typically involved with managing multiple proposals, contracts, and vendors, while creating the potential for meaningful process improvements that improve long term value. 4

7 Functional Expertise Biostatistics and Statistical Programming inventiv Health Clinical biostatisticians have a broad knowledge base in all aspects of clinical trials, from the initial stage of planning the design and calculating sample size requirements, to analyzing, displaying and interpreting data in the final stages of the study. inventiv Health Clinical experts, which consists of Ph.D. and MS-level statisticians and statistical programmers, plan the analyses you ll need before the study begins, then provide reports, statistical summaries, and efficacy and safety analyses promptly and accurately as the study progresses. We can leverage our vast statistical experience to design studies in a way that speeds submissions. Our thorough validation and quality control processes will eliminate the need for corrections and ensure accurate results. By applying standard templates and programs with customization as needed, we will provide efficient, high quality analyses for your project. Some of our unique expertise includes: Thought leadership and operational experience with CDISC standards, both SDTM and AdaM Integrated safety and efficacy summaries Adaptive design consulting and simulation support Data monitoring board management and support Automated QC process, including a CDISC compliance checker We provide additional services including: At inventiv Clinical Health, we have a unique set of capabilities in biostatistics and statistical programming that set us apart. Approximately 40% of our programmers have biostatistics training. inventiv Health Clinical is also an active participant on the SAS Leadership Council. Protocol development, including sample size and power calculations Randomization schedules Statistical analysis plans Statistical programming in SAS Statistical analyses using current methodologies Interpretation and reporting of data for clinical trial reports and publications Statistical and strategic consulting for product development Interim analysis for early decision-making Database integration NDA-ready data listings CDISC-compliant datasets 5

8 Functional Expertise Clinical Monitoring With over twenty years of experience building and managing monitoring programs for some of the most highly respected biopharmaceutical companies in the industry, inventiv Health Clinical possesses the expertise to thoroughly understand the needs of our clients and has the geographic reach and access to qualified talent to respond quickly to execute customized solutions. Our solutions leverage innovative approaches to optimize workforce management practices and streamline monitoring processes in order to maximize both quality and efficiency in the delivery of our services. Consistent with the new guidance from regulatory authorities on risk-based monitoring, we believe that the monitoring strategy needs to reflect the individual needs of the study. In addition to traditional on-site monitoring, we leverage modern monitoring strategies that are focused on the potential risks that would affect the reliability of the study data. These include the use of targeted on-site monitoring, centralized remote monitoring, and real-time review of clinical data using statistical analysis to identify trends and outliers. Clinical monitoring services include: Protocol feasibility assessment Site feasibility assessment Site identification and study-start up Investigator/ site staff training CRF design input Study Monitoring Plan development Informed Consent translations Patient eligibility confirmation Patient recruitment consulting & tracking against targets Source document verification (100% or reduced) Unblinded drug monitoring Investigational Product compliance monitoring Adverse Event reporting Quality risk assessment Regulatory compliance monitoring/capa plans Regulatory documentation maintenance 6

9 Functional Expertise Data Management At inventiv Health Clinical we take an innovative approach to clinical data management that s shaped by superior industry experience. Our depth of experience enables us to precisely pair technology and proven processes with clinical studies to help streamline the route to more efficient and effective data collection and management. InVentiv Health Clinical s study-specific approach to data management begins with a careful review of the study specifications, client preferences/history, data to be collected, and technologies available. We then provide guidance to clients on the most appropriate method for data collection to best serve the needs of study sites and project team. Our robust, scalable and software-independent processes enable us to efficiently capture, maintain, clean and deliver data for your project regardless of phase, therapeutic area, size, or method of data capture. We have extensive experience working in sponsor-hosted technologies and can follow inventiv Health Clinical or our client s SOPs. If a software preference is not identified, we have expertise in a variety of software applications and can recommend one that is right for your study. Our unique experience in consulting and operationalizing CDISC / SDTM standards for our clients includes data consolidation, migration, and conversion. In addition, we offer a full suite of comprehensive data management services utilizing EDC and/or traditional paper data capture methods including: Case Report Form (CRF)/eCRF design Database design, implementation Data validation, review, and cleaning Medical coding All data management processes are inspected by an independent management quality control team Comprehensive management of data from third-party electronic data vendors Study rescue services Consultation and data management strategies, systems, procedures, and metrics InVentiv Health Clinical utilizes the latest technology releases and best practices for efficiently designing and supporting studies in their platforms. In addition, we maintain active relationships with multiple electronic data vendors which ensures we can efficiently integrate and work with these systems. 7

10 Functional Expertise Medical Writing Clear, concise, and professional presentation of study findings is an important factor in any development program. With a full complement of medical writing services, inventiv Health Clinical professionals can provide all your documentation and writing needs. Comprised of scientists, many with advanced degrees, our medical writing team has significant expertise in key therapeutic areas of pharmaceutical and biotechnology clinical development. They work directly with you to ensure consistency with your format and style while maintaining full compliance with regulatory requirements and International Conference on Harmonisation (ICH) guidelines. InVentiv Health Clinical has a proven track record of timely delivery of quality medical writing deliverables coupled with outstanding customer service. We employ more than 160 writers, editors, and writing management staff. Their broad range of expertise includes preparation of regulatory documents, commercialized and safety related documents. Therapeutic experience includes neuroscience, oncology, cardiovascular, critical care, autoimmune, diabetes/endocrine, infectious disease, men s health, women s health, and osteoporosis/bone metabolism. InVentiv Health clinical is unique in this area because we offer the full spectrum of regulatory and commercial documents from Phase I through Phase IV, safety aggregate report writing, and we hire only experienced medical writers. Our complete list of medical Writing services includes: Regulatory Writing Protocols and protocol amendments Informed Consent Forms/ Patient Information Leaflets Clinical study reports Subject narratives Investigator Brochures Integrated summaries of safety/efficacy Literature summaries Scientific Manuscripts Manuscripts Abstracts Posters Symposia publications Slide presentations Publication plans Clinical expert reports INDs, NDAs, BLAs, CTAs (Module 2) summary documents IND and NDA Annual reports Safety Aggregate Reports (PSURs, PADERS, Line Listings, DSURs) Clinical trial registry synopses 8

11 Functional Expertise Project Management InVentiv Health Clinical sets industry standards for the quality of our professionals, the tools they use, and the strategies and efficiencies they bring to managing projects. Through a sound team structure, close communication, and detailed tracking and measurement, our Project Management group delivers consistently high quality for our clients. We optimize productivity through technology and training, and our processes are engineered for efficiency and quality. By providing an approach that is consistent and predictable, we can keep projects running on time and on budget and manage change along the way. We track key metrics and milestones for every project, and by agreeing on these ahead of time with our clients, we can lay a foundation for reporting, continual improvement, and demonstration of success. We differentiate ourselves in the discipline of project management through: Depth of global experience, Therapeutic specialization Strategic partnership training and leadership Experience and training in the management of data services deliverables Each project manager works collaboratively with clients, from kick-off meetings to regular status reports, and stays in close contact with the sites through frequent communication and regular monitoring. We provide detailed tracking of each project and timely monitoring of data to help sponsors remain consistently aware of the status of their project. Understanding that a proactive effort ensures the best use of resources, inventiv Health Clinical s experienced project managers devote significant time and effort in the earliest stages of a project to planning and training. Using the latest technologies to track up-to-the-minute status of study data, project managers are at the hub of an exclusive program of continual assessment, feedback, and improvement. 9

12 Functional Expertise Global Safety and Pharmacovigilance InVentiv Health Clinical s Safety and Pharmacovigilance team supports clinical trials safety surveillance. Working globally, we can provide integrated or stand-alone services to support product safety monitoring in compliance with regulatory requirements for safety surveillance in pre- and post-approval settings. InVentiv Health Clinical has the flexibility and experience to deliver, whether our clients needs are best met on a project-by-project basis, through a functional service provider or consultative relationship. Of the greater than 30 active partnerships we have with our clients; several of them are focused specifically on pharmacovigilance. Our global, integrated team of skilled professionals has deep expertise in industry-specific pharmacovigilance services including drug safety, pharmacovigilance, and pharmacoepidemiology and a solid understanding of the changing regulatory environment. We have the capability to submit expedited and aggregate reports globally. Other services include: Case management SAE monitoring Expedited SAE reports SAE safety narratives Annual safety reports Safety database development and transfer Interim safety listings To manage clinical trial safety, the team can provide qualified medical analysis and review of all Serious Adverse Events (SAEs), and creates the necessary 21 CFR Part 11-compliant materials for submission to US and international regulatory authorities and data safety monitoring boards (DSMBs). We have unique offerings, such as risk management strategies, signal detection, REMS study consultation and delivery, litigation casework, and literature reviews. 10

13 Flexible Continuum of Outsourcing Services Performance Management Productivity Management Workforce planning Analysis of operational output Collaborative Process Improvement Broad operational strategy Process/SOP development and improvement Shared governance Staff Lift Out Strategic partnership Complete functional execution and support Your employees become our employees Staffing Provide client / home based staff, F/T or P/T that you manage Provide full recruitment, contract and payroll support Bill hourly/daily Training On-boarding Dedicated line management Performance Management Career development Develop/ report KPIs Deliverable based pricing STRATEGIC ROI VARIABLE COST RATIO

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16 14 Initiator is a trademark of Perceptive Informatics. inventiv Health. All rights reserved. January PHSI02-04