Welcome to Clynergy

/clin-ər-jē/

Noun. The reciprocal action of two or more individuals or organizations to produce a combined effect that is greater than the sum of their separate effects in furthering clinical advancements for the benefit of humanity.

 

Clynergy brings more than 20 years of international, cross-functional clinical research experience in all study phases and a wide range of products, including pharmaceuticals, biologics, medical devices, and digital therapeutics. Our services include, but are not limited to organizational consulting, quality management, clinical management and oversight, program and project management, risk management, technical writing and editing, and inspection readiness for sponsors and CROs of all sizes.

The
Clynergy
Difference

Experience Counts

 

22

Years of Experience

33

Indications

21

Countries

80

Clinical Trials

 

Our Values

 

Partnership

Clynergy is about synergy in clinical research. We regard each client and each project as a unique alliance of infinite potential.

Innovation

We think outside the box and recognize the difference between the correct approach
– of which there are often many – and the best approach.

Efficiency

As a boutique consulting firm, our services are competitively-priced, free of overhead, and catered to the individual needs of each client.

Expertise

Clynergy is well-versed in the latest transnational, technology-driven, and multi-cultural strategies for clinical research and monitoring in an evolving regulatory environment.

 

Our Services

 

Clinical Management

Our goal is to help you bring your leading-edge products and therapies into a clinical trial setting, where patient safety is key and quality results, a must. Moreover, as you step onto the overseas regulatory terrain, we can help you bridge the cultural, communication, and compliance differences that can – and often do – result in undesirable consequences in the conduct of clinical trials.

Clinical Management

Whether you are looking for limited support or full-scale project development, we are committed to meeting your unique clinical research needs, by providing you with the following customized services:

  • Project development and management;
  • Site management and monitoring services;
  • CRO/vendor selection and strategic management;
  • Bid preparation, submission, and defense;
  • Sponsor/CRO/Vendor partnership development;
  • Integrated data review leadership;
  • Electronic Trial Master File (eTMF) development;
  • Training module and matrix development; and
  • Coaching and field training for CRAs and other staff.
 

Clinical Oversight

With human lives at stake, dedicated oversight is more than just an added value in clinical research. It’s a legal obligation, as well as a critical process for ensuring reliable study data, regulatory compliance, and strong teamwork. At Clynergy, we help bridge the gap between the study sponsor and the clinical research organization by continuously and objectively assessing progress and performance at every stage of the clinical trial.

Clinical Oversight

As seasoned research professionals, with an extensive background in clinical operations, quality management, and regulatory affairs, we can help extend your oversight function by providing the following services and more:

  • Oversee CRO conduct of clinical trial monitoring;
  • Central and remote monitoring innovation and leadership;
  • Monitoring visit report review and issue trending;
  • Corrective and Preventive Action (CAPA) management;
  • eTMF review and auditing;
  • Onsite and remote oversight visits with CRO CRAs;
  • Inspection readiness consulting;
  • Process improvement and innovation; and
  • Quality Assurance activities.
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Risk Management

In the clinical research world, risk assessment and mitigation provide the ultimate safety net when it comes to increasing patient safety, improving data quality, and achieving desired trial results. That said, it makes sense to invest in the expertise you need to oversee a well-orchestrated process for proactively assessing and mitigating study risks before they become costly and dangerous problems.

Risk Management

Our tried and true risk management approach is grounded in the following services to ensure a systematic and structured, customized and collaborative approach that meets industry guidelines:

  • Analysis of critical data and critical processes;
  • Risk identification, evaluation, and mitigation;
  • Risk Assessment Categorization Tool (RACT) management;
  • Risk-based Monitoring (RBM) modeling and implementation;
  • Risk meetings, issue tracking, and resolution;
  • Study dashboard implementation and monitoring; and
  • Key Risk Indicators (KRIs) and Quality Tolerance Limits (QTLs).
 

Writing and Editing

When it comes to high-quality medical and technical writing, we usually think in terms of streamlined, polished, and error-free documents. But what about the relevance of the content and its success rate in and out of the clinic? The answer here lies in knowing your audience. That’s why we build upon our diverse experience to help clients deliver high-caliber documents that are also highly relevant and effective.

Writing and Editing

Drawing from a strong operational background, thousands of onsite hours, and a knack for the written word, we offer the following writing and editorial services:

  • Clinical protocols;
  • Standard Operating Procedures (SOPs);
  • Study Management Plans (e.g. Clinical Monitoring Plan, eTMF Plan, etc.);
  • Site-level documents (e.g. operations manuals, study logs and forms, etc.);
  • Informed consent forms;
  • Documents in support of regulatory submissions; and
  • Slideshow presentations and other visuals.
 

Clynergy is Led by Ned French

Ned French is a well-rounded expert in the field of clinical research, with more than 20 years of experience in a variety of roles and functions, including Program Management, Clinical Study Management, Training Management, Quality Managment, Outsourcing, Clinical Monitoring, and more. He has overseen studies in Phase I facilities, major university hospitals, smaller hospitals, and private practices throughout North America and Europe, working in a broad range of therapeutic areas, including nephrology, central nervous system, hematology, immunology, neurology, gastroenterology, and surgery.

 

Ned specializes in organizational consulting; quality management; clinical management and oversight; program and project management; risk management; technical writing and editing; and inspection readiness for sponsors and CROs of all sizes.

In addition to having managed more than 30 in-house studies in support of placebo and product delivery prototype development, Ned has actively supported 80 clinical trials, including orphan, biologic, pharmaceutical, digital therapeutic, and medical device trials. Ned also takes special interest in rare diseases, pediatric research, and rescue studies.

Having steadily worked his way up through the ranks, in both sponsor companies and clinical research organizations, Ned not only understands the “bigger picture,” he also knows first-hand the power of synergistic teamwork in conducting successful clinical trials.

In addition, he has spent more than a decade based in the international marketplace. Consequently, he is uniquely positioned to design and deliver consulting services that are project-relevant, highly customized, and culturally sensitive.

Ned holds a Bachelor of Science degree in Psychology, as well as three high-profile professional certifications – Project Management Professional (PMP), Certified Clinical Research Associate (CCRA) and Certified Clinical Research Professional (CCRP) – which speak to his proven knowledge of the regulations, guidelines, and best practices in the field of clinical research. He is also fluent in English and German.

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