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Navitas Life Sciences

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Princeton, New Jersey, US

About Navitas Life Sciences

In today’s increasingly complex clinical development environment, life sciences companies are faced with pressures from regulators, payers, and the public to manage clinical trials that are safe, cost-effective, and informed by big data and technology. To ensure the best possible outcomes for their product,... Show more »

In today’s increasingly complex clinical development environment, life sciences companies are faced with pressures from regulators, payers, and the public to manage clinical trials that are safe, cost-effective, and informed by big data and technology. To ensure the best possible outcomes for their product, life sciences companies need a reliable, experienced partner who understands how to make insight-driven decisions at every stage of the clinical development pipeline.

With a rich legacy of experience and expertise, Navitas Life Sciences has partnered with life sciences companies to achieve their desired outcomes in clinical development.

Navitas, the dedicated life sciences company of TAKE Solutions, harnesses the combined knowledge and experience of three legacy companies—Ecron Acunova, Navitas, and Intelent—to provide end-to-end services and solutions. We help our clients address their most critical problems by bringing together the capabilities of a full-service CRO, a technology-led life sciences services provider across clinical, regulatory and safety, and a life sciences big data services and analytics provider.

We pride ourselves on being flexible, innovative, reliable, and passionate. We are motivated by the success of our clients and thrive on working together with clients as partners, across geographies, time zones, and cultures.

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Our Services (22)


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Phase III Clinical Trials

Price on request

Delivering Successful Outcomes for Phase II and Phase III Trials

Clinical trials sponsors face the challenge of staying patient-centric and ensuring regulatory compliance, all while delivering shareholder value. This means that sponsors need to:

  • Operate more efficiently, delivering high quality data, faster, at a competitive... Show more »

Delivering Successful Outcomes for Phase II and Phase III Trials

Clinical trials sponsors face the challenge of staying patient-centric and ensuring regulatory compliance, all while delivering shareholder value. This means that sponsors need to:

  • Operate more efficiently, delivering high quality data, faster, at a competitive cost to reduce the cost of drugs
  • Operate differently, with collaborative, cost-effective and efficient operating models to deliver increased value from marketed drugs
  • Leverage capabilities of global partners, particularly to access emerging markets

Navitas is your Reliable Partner in Clinical Trial Management

In the digital health revolution age, Navitas Life Sciences serves as an integrated development partner for faster and more cost-effective management of Phase II-III trials. We have served global sponsors in pharma, biotech, medical device, diagnostic, and consumer health companies across America, Europe and Asia. Our work has led to long standing relationships of continuous service with leading sponsors.

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Phase II Clinical Trials

Price on request

Delivering Successful Outcomes for Phase II and Phase III Trials

Clinical trials sponsors face the challenge of staying patient-centric and ensuring regulatory compliance, all while delivering shareholder value. This means that sponsors need to:

  • Operate more efficiently, delivering high quality data, faster, at a competitive... Show more »

Delivering Successful Outcomes for Phase II and Phase III Trials

Clinical trials sponsors face the challenge of staying patient-centric and ensuring regulatory compliance, all while delivering shareholder value. This means that sponsors need to:

  • Operate more efficiently, delivering high quality data, faster, at a competitive cost to reduce the cost of drugs
  • Operate differently, with collaborative, cost-effective and efficient operating models to deliver increased value from marketed drugs
  • Leverage capabilities of global partners, particularly to access emerging markets

Navitas is your Reliable Partner in Clinical Trial Management

In the digital health revolution age, Navitas Life Sciences serves as an integrated development partner for faster and more cost-effective management of Phase II-III trials. We have served global sponsors in pharma, biotech, medical device, diagnostic, and consumer health companies across America, Europe and Asia. Our work has led to long standing relationships of continuous service with leading sponsors.

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Clinical Trial Design and Consulting

Price on request

With the estimated cost of bringing a drug to market at $2.5 billion and the probability of success of getting to the market from phase 1 at less than 10%, clinical operations have never faced a more challenging environment than now.

While a typical phase 3 trial generates 900,000 data points, many companies still rely on Excel... Show more »

With the estimated cost of bringing a drug to market at $2.5 billion and the probability of success of getting to the market from phase 1 at less than 10%, clinical operations have never faced a more challenging environment than now.

While a typical phase 3 trial generates 900,000 data points, many companies still rely on Excel spreadsheets to bring data together from traditionally silo-ed sources. This takes time which limits the ability to drive decisions off clinical data in real time.

Monitoring services predominantly rely on routinely scheduled site visits to verify source data, resulting in high travel costs, and inefficient processes. 100% source data verification accounts for up to 25% of trial costs. However, it does not contribute to data quality value, instead alternative, risk based, approaches can benefit patient safety without such a significant cost contribution.

Inspection findings reflect this complex picture, with critical findings from EMA, MHRA and FDA focused on the following areas:

  • Data capture, clean-up, analysis, integrity and management
  • Risk based monitoring
  • Sponsor trial management and CRO oversight
  • TMF, QMS and essential document management

Reflecting these findings, the ICH GCP guidelines have been revised in 2017, thereby adding a further compliance challenge for clinical operations.

Navitas Life Sciences Creates Impactful Results for Sponsors Through an Integrated Approach

Our global clinical consultants apply their extensive expertise and knowledge to guide sponsors to achieve their strategic objectives through best practices. With over 30 years of experience of supporting Life Sciences companies, breakthrough insights gained through our industry network forums, models for success, and proven structured approaches, Navitas Life Sciences serves as a trusted strategic advisor.

Our breadth and depth of experience has taught us that there is no one-size-fits-all solution. We take a personalized approach to each client situation to ensure results are grounded in industry best-practices, but tailored to specific needs, fit-for-purpose, cost-effective, scalable, and compliant. Engagements begin with a detailed current state assessment to prioritize improvement opportunities and continue beyond pragmatic recommendations to include detailed solution design and implementation. This includes managing the change, developing / revising controlled documents, incorporating revised responsibilities into role descriptions, and developing training plans and materials for roll-out across functional stakeholders.

By including our clients’ subject matter experts, who have deep institutional knowledge, prominently on project teams, improvements are implemented smoothly to ensure project benefits continue to be realized beyond the end of our contractual engagement.

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Medical Imaging Services

Price on request

Medical Imaging in clinical trials provides sponsors the key advantage of quick visual confirmation of drug efficacy, thus significantly reducing the time, risk and cost associated with clinical trials. Hence, Medical Imaging is fast emerging as a critical endpoint for a variety of clinical trials across several therapeutic... Show more »

Medical Imaging in clinical trials provides sponsors the key advantage of quick visual confirmation of drug efficacy, thus significantly reducing the time, risk and cost associated with clinical trials. Hence, Medical Imaging is fast emerging as a critical endpoint for a variety of clinical trials across several therapeutic coverages, especially Oncology, Musculoskeletal and Neurology.

To best leverage imaging endpoints, sponsors require a partner who provides high quality, accurate data analysis, through validated systems to ensure compliance. Success of imaging endpoints is a result of ensuring imaging experts are backed by validated technology solutions to provide seamless support to sponsors throughout the trial.

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Clinical Bioavailability/Bioequivalence Studies

Price on request

100+ Marketing Authorizations Obtained Through our Bioavailability & Bioequivalence Study Services

With over 90% of the prescriptions in the US market being fulfilled by generics companies, the competition in this space is growing exponentially. This makes it imperative for generics companies to be first-to-market, while... Show more »

100+ Marketing Authorizations Obtained Through our Bioavailability & Bioequivalence Study Services

With over 90% of the prescriptions in the US market being fulfilled by generics companies, the competition in this space is growing exponentially. This makes it imperative for generics companies to be first-to-market, while adhering to stringent regulatory requirements, ensuring high quality outputs, and maintaining a cost advantage

Navitas Life Sciences Delivers Outcomes Through High Quality BA / BE Studies and Beyond

Navitas Life Sciences provides clients with End-to-End Bioavailability & Bioequivalence services for generics companies. Our services include study design, conduct, bioanalysis, data standardization and analysis, dossier preparation and regulatory submissions, and pharmacovigilance.

With a highly qualified and experienced team in place, Navitas can deliver even complicated studies with high quality outputs. We have experience in a wide variety of studies including multiple doses, dosage form, dose escalation, single and double blind, PK/PD end point studies, Glucose clamp studies, proof of concept and exploratory, repeat “first in man”, nutritional, special population, drug interaction, and more.

All of our infrastructure and systems are setup to guarantee high-quality outputs and compliance for generics companies. Our state-of-art facilities have been inspected successfully by the USFDA, WHO, Health Canada, EMA, DCGI, TGA & NPC, among other regulators. We are ISO 9001, ISO 27001, and ISO 15189 certified, and are accredited by the College of American Physicians.

Thus, Navitas Life Sciences provides comprehensive and personalized services from a highly skilled team, backed by high-quality infrastructure and systems, enabling high-quality outcomes for Generics companies.

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Biopharmaceutical Development

Price on request

Delivering Results for Biologics & Biosimilars Manufacturers

With patents expiring on all of the top 30 biological drugs before 2025, this is an exciting time for Biosimilar launches. To be first to file, Sponsors require a partner with advanced technical and regulatory expertise. The main considerations for a sponsor while... Show more »

Delivering Results for Biologics & Biosimilars Manufacturers

With patents expiring on all of the top 30 biological drugs before 2025, this is an exciting time for Biosimilar launches. To be first to file, Sponsors require a partner with advanced technical and regulatory expertise. The main considerations for a sponsor while selecting a partner to enable successful biosimilar study are:

  • Extensive clinical experience to monitor and treat potential severe adverse responses to biosimilar drug
  • Ability to design lean protocols to gain market approval as efficiently as possible
  • Focus on cost efficiency to capture market share
  • Track record of meeting regulatory requirements for study quality remain as high as innovator research

Navitas has Proven Expertise with Biologics and Biosimilars

With a global presence, our experience across innovator pharma and biologic Phase III studies, and pharmacokinetic studies enables us to partner with you to meet accelerated submission timelines while optimizing trial costs and regulatory risk of non-compliance.

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Observational Research/ Non-Interventional Studies

Price on request

Driving Outcomes for PASS, PAES and other Non-Interventional Studies

Real-world evidence of drug use in various patient populations is essential to understanding the value of a therapy. The expectations and demands of a non-interventional study are manifold:

  • Quality of data must remain high: non-interventional study data has... Show more »

Driving Outcomes for PASS, PAES and other Non-Interventional Studies

Real-world evidence of drug use in various patient populations is essential to understanding the value of a therapy. The expectations and demands of a non-interventional study are manifold:

  • Quality of data must remain high: non-interventional study data has been used to support marketing authorization
  • Post approval drug costs are estimated at $312 million. Yet cost expectations around non-interventional studies are low, given lower risk of such studies and reduced need to comply with GCP
  • Regulations around non-interventional studies are not harmonized around the world, requiring highly experienced staff to conduct studies

However, the real-life situation of such post-authorization studies makes them inherently complex, requiring advanced data handling capability for successful outcomes.

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Observational Research/ Non-Interventional Studies

Price on request

Driving Outcomes for PASS, PAES and other Non-Interventional Studies

Real-world evidence of drug use in various patient populations is essential to understanding the value of a therapy. The expectations and demands of a non-interventional study are manifold:

  • Quality of data must remain high: non-interventional study data has... Show more »

Driving Outcomes for PASS, PAES and other Non-Interventional Studies

Real-world evidence of drug use in various patient populations is essential to understanding the value of a therapy. The expectations and demands of a non-interventional study are manifold:

  • Quality of data must remain high: non-interventional study data has been used to support marketing authorization
  • Post approval drug costs are estimated at $312 million. Yet cost expectations around non-interventional studies are low, given lower risk of such studies and reduced need to comply with GCP
  • Regulations around non-interventional studies are not harmonized around the world, requiring highly experienced staff to conduct studies

However, the real-life situation of such post-authorization studies makes them inherently complex, requiring advanced data handling capability for successful outcomes.

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Clinical Data Management

Price on request

For a clinical trial to be successful, it is essential to have high-quality data, delivered in a timely fashion, in compliance with the prevalent regulatory requirements.

We partner with you to deliver full clinical data services across Clinical Data Management, Biostatistics & Statistical programming, Clinical Data... Show more »

For a clinical trial to be successful, it is essential to have high-quality data, delivered in a timely fashion, in compliance with the prevalent regulatory requirements.

We partner with you to deliver full clinical data services across Clinical Data Management, Biostatistics & Statistical programming, Clinical Data Standardization, and Medical Writing. With our flexible, scalable and global delivery model, our teams can be onsite, offshore, near shore or a combination, depending on your short- and long-term objectives. We leverage our proven OneClinical platform or your chosen platform to ensure high quality and compliant deliverables with improved turnaround times and lower cost.

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Regulatory Document Preparation and Submission

Price on request

Regulatory Operations teams face significant challenges in managing the submissions activities within life sciences organizations. These include; National differences and changes to submissions requirements (even in the era of the Common Technical Document and the eCTD), fluctuating internal submission workloads, and the... Show more »

Regulatory Operations teams face significant challenges in managing the submissions activities within life sciences organizations. These include; National differences and changes to submissions requirements (even in the era of the Common Technical Document and the eCTD), fluctuating internal submission workloads, and the coordination of vast amounts of scientific and medical information and data from a wide variety of contributors. Often this needs to be achieved while utilizing all-too-often disconnected IT tools that do not provide an adequate and tightly integrated view of the end-to-end process. Add to this scenario the need to speed new therapies to market while also turning around a variety of post approval submissions related to a portfolio of mature products. These persistent challenges continue to drive Regulatory Operations leads towards creative operating models that provide workforce flexibility, greater efficiency, high quality submissions, and 24 by 7 follow-the-sun global operations.

How Can Navitas Life Sciences Help?

From our State-Of-The-Art Regulatory Processing Center in Chennai, India as well as our South American hub in Columbia, Navitas Life Sciences offers document, report and submission level publishing for both simple and complex submission applications including life cycle management. In addition, Navitas Life Sciences also provides invaluable subject matter expertise in evolving electronic submissions standards, health authority specific guidelines and processes. We have extensive electronic submissions experience gained from serving a wide range of customers and life sciences companies across the globe.

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Regulatory Affairs Consulting

Price on request

The regulatory landscape is a constantly evolving, one with increasing emphasis on ensuring patient safety. This fluid environment presents challenges to departments whose mandate is to manage and extract value from the vast amounts of structured and unstructured information and data, whilst ensuring their organizations stay... Show more »

The regulatory landscape is a constantly evolving, one with increasing emphasis on ensuring patient safety. This fluid environment presents challenges to departments whose mandate is to manage and extract value from the vast amounts of structured and unstructured information and data, whilst ensuring their organizations stay compliant with the myriad of global, regional and local requirements. The increased focus on Marketing Authorization Holders’ ability to manage product information as well as their capability to track and monitor safety and benefit-risk information throughout the life cycle of their products, requires organizations to put in place fit-for-purpose and robust systems, processes and governance.

With a consulting team that brings over 100 years of combined experience to help sponsors navigate the regulatory landscape of their organization, Navitas Life Sciences consultants serve as trusted advisors, providing strategic counsel backed by years of experience, industry benchmarks and insights. Our breadth and depth of experience has taught us that there is no one-size-fits-all solution. We take a personalized approach to each client situation to ensure results are grounded in industry best-practices supported by our industry networks labelnet and rimnet, tailored to specific needs, as well as being fit-for-purpose, cost-effective, scalable and compliant.

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Pharmacovigilance and Post-Authorization Safety Studies (PASS)

Price on request

Navitas Life Sciences is a full-service Pharmacovigilance provider, offering Services along the PV Value chain right from Case Intake to Safety Risk Management. With operating centers in Germany and India, Navitas provides a combination of offshore and onshore teams that can reliably serve the entire PV spectrum.

Navitas Life Sciences is a full-service Pharmacovigilance provider, offering Services along the PV Value chain right from Case Intake to Safety Risk Management. With operating centers in Germany and India, Navitas provides a combination of offshore and onshore teams that can reliably serve the entire PV spectrum.

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Medical Device Development Consulting

Price on request

At Navitas, we have a track record of successful medical device project delivery across many areas, including regulatory affairs, quality management, risk management, device vigilance and track & trace technologies. We offer deep industry insight, paired with project management experience, and work along the three dimensions of... Show more »

At Navitas, we have a track record of successful medical device project delivery across many areas, including regulatory affairs, quality management, risk management, device vigilance and track & trace technologies. We offer deep industry insight, paired with project management experience, and work along the three dimensions of processes, people and technology.

We serve clients from the life science industry across multiple regions. We deliver services, technologies, and consultancy engagements to the medical device, biotech, and pharmaceutical sectors. We pride ourselves on our industry leading Networks, setting us apart from our competitors. We are happy to work in large or small teams, depending on the assignment and client requirements. We focus on customer needs and measure both progress and success. Our staff are expert navigators, fulfilling the role of project manager as well as being subject matter experts, delivering value from day one.

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Clinical Trials, Consulting, and Management

Price on request

Clinical Trials, Consulting, and Management Services

Clinical Trials, Consulting, and Management Services

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Clinical Laboratory Services

Price on request

Clinical Laboratory Services

Clinical Laboratory Services

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Drug Development

Price on request

Drug Development Services

Drug Development Services

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Drug Discovery & Development

Price on request

Drug Discovery & Development Services

Drug Discovery & Development Services

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Clinical Data Collection, Analysis and Management

Price on request

Clinical Data Collection, Analysis and Management Services

Clinical Data Collection, Analysis and Management Services

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Regulatory Affairs Services

Price on request

Regulatory Affairs Services

Regulatory Affairs Services

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Epidemiology, Healthcare, and Post-Authorization Studies

Price on request

Epidemiology, Healthcare, and Post-Authorization Studies Services

Epidemiology, Healthcare, and Post-Authorization Studies Services

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Clinical Research

Price on request

Clinical Research Services

Clinical Research Services

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Medical Devices & Diagnostics

Price on request

Medical Devices & Diagnostics Services

Medical Devices & Diagnostics Services

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