Resources
The Role of Skin barrier Dysfunction in Atopic Dermatitis—The Microbiome
Table of contents Cutaneous Dysbiosis Interplay S. aureus: Its Interaction and Impact on Skin S. aureus and Inflammation Focusing on the microbiome, Staphylococcus aureus (S. aureus) is a widespread bacterium that produces a multilayer biofilm, was shown to colonize the skin and play a critical role in Atopic Dermatitis (AD). Over 70% of people are […]
Enhancing Clinical Performance and Cost Efficiency: The Significance of Protocol Writing in Dermatology Trials
Did you know that protocol amendments are not only common, but also very costly? In fact, as per a recent article by Getz K. et al., 57% of protocols had at least one substantial amendment with an average of 2.3 global amendments for phase 2 and phase 3 studies. The cost to implement one protocol amendment was $141,000 US for a phase 2 study and $535,000 US for a phase 3 study. To avoid unnecessary hassle and expenses, take the time to ensure your protocols are well written and top-notch quality.
How to Write First-Rate Protocols for a Psoriasis Study - Focus: Study Design
The success of any clinical study is dependent upon a sturdy protocol; the overall quality of the study depends on this very document. This is especially true for multicenter studies which involve many investigators and clinical staff. This article will explore the best tips to deliver first-rate protocols in psoriasis to set you apart from the competition. Innovaderm Research Inc specializes in a spectrum of dermatological indications, namely acne vulgaris, atopic dermatitis, and psoriasis.
Dr. Robert Bissonnette and Dr. Kim Papp on Alopecia Areata Insights
Dr. Robert Bissonnette from Innovaderm Research and Dr. Kim Papp from Probity Medical Research (PMR) met at the 2023 EADV for an engaging conversation focused on the intricacies of early phase studies and explored the significant challenges of conducting vitiligo studies. In this article, we shift the focus on alopecia areata (AA) studies insights, exploring the experiences of these seasoned dermatologists.
Dr. Robert Bissonnette and Dr. Kim Papp on the Intricacies of Dermatology Early Phase Clinical Research
Amidst the bustling 2023 EADV in Berlin, Dr. Bissonnette from Innovaderm Research and Dr. Papp from Probity Medical Research (PMR) found a unique opportunity for an engaging conversation. The pair covered some of the main challenges encountered with conducting vitiligo studies and insights on alopecia areata (AA) studies. This article will focus on early phase studies.
Dr. Robert Bissonnette and Dr. Kim Papp on Navigating the Challenges of Vitiligo Research Trials
Dr. Bissonnette from Innovaderm Research and Dr. Papp from Probity Medical Research (PMR) took a moment between presentations at the 2023 EADV for an interesting industry talk where the duo covered the intricacies of early phase studies and some of the main challenges encountered with conducting alopecia areata (AA) studies. However, the spotlight of this article will be on vitiligo studies. This piece aims to explore the complexities and the latest advancements in vitiligo research.
Dr. Robert Bissonnette and Dr. Kim Papp on Shaping the Future of Clinical Research
For the occasion of the 2023 EADV, Dr. Bissonnette from Innovaderm Research and Dr. Papp from Probity Medical Research (PMR) seized a rare moment to engage in a compelling conversation. These industry leaders share a common journey—the conception and evolution of their clinical research companies, which began as local endeavors in Canada and blossomed into influential international entities. The pair covered some of the main challenges of conducting vitiligo studies, the intricacies of early phase studies, and offered insights into alopecia areata (AA) studies. This exclusive interview will bring to light the pivotal role these entities play in shaping the future of clinical trials.
"Clinical Development Strategy that Patients Need and Investors Want" by Dr. Jasmina Jankicevic
Innovaderm is thrilled to announce that our team was present at the AID Dermatology Summit in San Francisco on January 7th! Our very own Chief Medical Officer, Dr. Jasmina Jankicevic, delivered an insightful presentation titled “Clinical Development Strategy that Patients Need and Investors Want”. ⭐ Dr. Jankicevic's talk was nothing short of incredible, shedding light […]
Nimbus Testimonial
Innovaderm is proud of its partnership with Nimbus Therapeutics for an investigational oral TYK2 inhibitor, in a Phase 2b trial for patients with moderate-to-severe psoriasis. Innovaderm’s reputed teams once again proved their expertise throughout the whole project, from the study design all the way to the trial reports, under tight timelines. “There are many CRO […]
Dr. Robert Bissonnette and Dr. Kim Papp on Shaping the Future of Clinical Research
Amidst the vibrant atmosphere of the EADV in Berlin, Dr. Bissonnette from Innovaderm Research and Dr. Papp from Probity Medical Research seized a rare moment between presentations to engage in a compelling conversation. These industry leaders share a common journey—the conception and evolution of their clinical research companies, which began as local endeavors in Canada […]
Innovaderm, a Key Collaborator in Clinical and Study Development for Recently Published Phase 1 Atopic Dermatitis Study
[MONTREAL, QUEBEC — December 19, 2023] Allergy recently published RAPT Therapeutics’ phase 1a/1b atopic dermatitis (AD) study, in which Innovaderm Research was a key partner, serving as the contract research organization (CRO). This was a first-in-human and proof of concept randomized, placebo-controlled Phase 1a/1b monotherapy study to evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics, and CCR4 […]
Best Practices in Skin Microbiome Sample Collection
Our skin is home to millions of microorganisms which play an important role in the innate and adaptive cutaneous immune system and the overall maintenance of our skin barrier. Dysbiosis has been shown to be associated with many skin diseases. Having a better understanding of the skin microbiome to allow dysbiosis reversal is critical for the development of new skin disease therapies. Integrating skin microbiome sample collection in clinical trials is a great opportunity to assess the impact of changes in microflora on skin disease state. Skin microbiome sampling can be a simple and quick process, however the following key elements must be considered to ensure quality samples:
Investigating Transdermal Analysis Patch (TAP) as a Non-Invasive Option for Biomarkers Studies
Conventional avenues to collect samples for the analysis of biomarkers have proven to necessitate intrusive procedures, engendering patient aversion and potential procedural hazards. Several recent non-invasive sampling approaches such as tape stripping, transdermal patch analysis and microneedling are making their way in dermatology clinical trials. This article will focus on transdermal patch analysis in an attempt to bring emphasis on the patient’s well-being and the preservation of the fidelity of acquired data. Transdermal analysis patches (TAPS) noninvasively measure soluble proteins in the stratum corne.
Using Biomarkers in Clinical Research
Clinical biomarkers ushered in a new era of possibilities in medicine by profoundly impacting the way we investigate and develop new treatment options. Non-invasive techniques such as tape stripping, transdermal analysis patch, and microneedling are transforming the dermatology clnical landscape. Biomarkers in clinical trials measure changes in protein, gene expression, or other biochemical pathways associated with a specific condition or response to a drug.
Exploring the Benefits of Tape Stripping in Dermatology Clinical Research
There are several approaches to study biomarkers using non-invasive techniques such as tape stripping, transdermal analysis patch and microneedling . This article will focus on the tape stripping method.
On the Edge of Dermatology Early Phase Trials
Watch this exciting webinar presented by Innovaderm Research in collaboration with Altasciences and be part of: Deep Dive in Study Design Discussion on SAD-MAD-POC Best Practices and Innovations From our early phase experts: Dr. Ana Palijan, Associate Director, Early Phase Department, Innovaderm Research Dr. Beatrice Setnik, Chief Scientific Officer, Altasciences Fareheen Chowdhury, Project Manager, Early […]
Conducting a Successful Medical Aesthetic Trial—Expert Strategies
The medical aesthetic market presents itself as a dynamic frontier with immense possibilities. Site selection, patient enrollment optimization, proper collection of relevant data, and proper operationalization set up, all have a direct influence on the progress of a medical aesthetic trial. Thus, closely exploring these key components will maximize a trial’s success.
Strategies for Effective Clinical Site Management
The successful management of a clinical trial is a fine balance between multiple significant elements; rather it is the feasibility aspect, patient recruitment, optimized protocol, etc. The relationship with the clinical research site is often a point that goes unnoticed. Clinical research sites are integral to the success of clinical trials and the pathway to this success begins with maintaining positive professional rapports between sites and CROs. Fostering this kinship will be paramount to the overall flow of your trial as well as for future site collaborations, expediency and efficiency of the study start-up, facilitated budget and contract negotiations and, overall streamed line activation process.
Unlocking the Market Potential of Medical Aesthetics
The medical aesthetics industry is an increasingly lucrative and rapidly developing sector of healthcare, currently valued at $13.9 billion and expected to reach a total of $23.4 billion by 2027. Despite this enticing profit potential, developers must consider the numerous challenges and emerging trends that will shape the future of this market.
Developing Dermal Fillers and Neuromodulators for Aesthetic Indications
Dermal fillers, also known as injectable implants, soft tissue fillers, or wrinkle fillers have been on the medical aesthetic market for over 30 years and have a variety of specific technological characteristics and indications. The successful conduct of a medical aesthetic clinical trial is dependent upon the development of an optimal study protocol, meticulous planning, and diligent implementation. The key protocol considerations for development of dermal fillers are detailed below.
Enhancing the Quality of Clinical Trial Data With 3D Photography
As the medical aesthetic market experiences robust growth, its accompanying technologies continue to evolve. Aesthetic trials use validated scales to evaluate the severity and improvement of a given condition in order to support efficacy endpoints. These evaluations are often performed as live local assessments at the site. However, as objective as these scales aim to be, these methods of assessment often lack standardization and introduce biases that can affect the reliability of the final results.
In-Person Breakfast Event at the AAD - Spotlight on Hidradenitis Suppurativa
Innovaderm was in New Orleans for the 2023 edition of the AAD congress and hosted its 4th Breakfast Event: Spotlight on Hidradenitis Suppurativa (HS). Listen to our world-renowned dermatology key opinion leaders' presentations to learn about HS and the latest research findings: Dr. Amit Garg, MD - Challenges of Current Scales & Development of Novel […]
Generalized Pustular Psoriasis (GPP) Rescue Case Study
Click here for a PDF version of this case study Outcomes Innovaderm successfully transitioned this rescue study from another CRO and this resulted in: More than doubled patient enrollment in 1 month Started enrollment 1 month faster than initial projection All 5 newly added sites were actively recruiting Study Characteristics Study Phase: IIa Study […]
3 Tips for Collecting Samples with Tape Stripping
Tape Stripping is a non-invasive option for the study of biomarkers in dermatology studies. Innovaderm is sharing its 3 best tips when performing tape strip collections. Let’s cover our bases, what is tape stripping? Tape stripping is used in dermatology studies to sample skin surface material by collecting a thin layer of cells from the […]
Centralized Monitoring: Exploring the Considerations and Challenges of Implementation
Innovaderm's Associate Director - Risk Based Quality Management, Rohit Gupta, contributed to PHUSE's white paper entitled: “Centralized Monitoring: Exploring the Considerations and Challenges of Implementation”. Innovaderm is proud to have been involved in the development of such a document addressing: 1. The key success measures & best practices to ensure a well-connected end-to-end component of […]
3 Tips on How to Manage Rosacea Trials
April is dedicated to raising awareness around Rosacea. One of Innovaderm’s all-star project managers, Nalanie Johnson, shared some tips that are crucial when managing a clinical trial to the complexity of a therapeutic indication such as Rosacea: 1. In managing Rosacea studies, it is important to understand the indication and patient flow. Most patients will […]
Hidradenitis Suppurativa (HS) Case study
Click here for a PDF version of this case study Outcomes Innovaderm successfully managed this HS study and this resulted in: Enrollment completed 3 months ahead of schedule Study Characteristics Study Phase: II Patient Population: Hidradenitis Suppurativa IP Route of Administration: Systemic - Subcutaneous Site distribution: 25 in North America and 16 in Europe […]
Clinical Trials Information System (CTIS)
📣Attention all clinical trial sponsors who are planning to conduct a study in the EU or EEA! Beginning on January 31, 2023, the Clinical Trials Information System (CTIS) must be used to submit any new clinical trial application in these regions. This new process permits a single application to secure authorizations in up to 30 […]
Palmoplantar Pustulosis (PPP) Case Study
Click here for a PDF version of this case study Outcomes Innovaderm successfully managed this PPP study and this resulted in: Enrollment completed 3 weeks ahead of schedule; Successful study and satisfied sponsor Study Characteristics Study Phase: II Patient Population: Palmoplantar pustulosis IP Route of Administration: Systemic Sites Distribution: 17 sites in 2 countries […]
Tips For a Successful Study in Medical Aesthetics
Watch this exciting and informative webinar about best practices on medical aesthetic studies from our industry experts. You will learn about: Insight into industry trends and key study design considerations; How to execute studies quickly without compromising data quality; Benefits and limits of qualitative image-derived evaluations From our industry Experts: Jasmina Jankicevic, Chief Medical Officer, […]
Notalgia Paresthetica (NP) Case Study
Click here for a PDF version of this case study Study Characteristics Study Phase: II Patient Population: 126 patients with Notalgia Paresthetica (NP) (Pruritus associated with NP) IP Route of Administration: Systemic (oral) Site Distribution: 33 sites (USA and Canada) Study Procedures: Photographs, Pharmacokinetics, Electrocardiograms Study Challenges Patient awareness: Challenge in advertisement as […]
Non-invasive methods to study molecular biomarkers in the skin: Tape Stripping and Beyond
Please join us for this unique webinar to learn more about non-invasive methods to collect and evaluate skin biomarkers in clinical trials. You will learn more about: Tape stripping techniques Sensitivity of various cutaneous biomarkers Non-invasive sample collection methods for skin protein and RNA analysis Questions? Contact us Newsletter Get notified to have […]
Alopecia Areata (AA) Case Study
Click here for a PDF version of this case study Outcomes Innovaderm’s outstanding support on this alopecia areata study resulted in a rapid increase in enrollment rates and the successful management of this trial Study Characteristics Study Phase: II Patient Population: Alopecia Areata IP Route of Administration: Systemic Sites distribution: 12 sites (CAD-USA) Complex […]
Atopic Dermatitis (AD) Case Study
Click here for a PDF version of this case study Outcomes Innovaderm successfully managed this AD study and this resulted in: Enrollment completed 2 months earlier than planned; Innovaderm CRU recruited 33% of patients Study Characteristics Study Phase: Ib Patient Population: 36 subjects with moderate to severe AD IP Route of Administration: Systemic - […]
Acne Case Study
Click here for a PDF version of this case study Outcomes Innovaderm successfully managed this acne study and this resulted in: Enrollment completed 1 month earlier than planned Study Characteristics Study Phase: II Patient Population: Acne vulgaris (enrolling pediatrics & adults) IP Route of Administration: Systemic Sites distribution: 15 sites (USA) Study […]
Palmoplantar Pustulosis (PPP) Rescue Case Study
Click here for a PDF version of this case study Outcomes Innovaderm successfully transitioned this rescue study from another CRO and this resulted in: Increase in enrollment of over 10x Tripled site performance post transition On-time patient recruitment Study Characteristics Study Phase: II Study Status: Rescue study Patient Population: Palmoplantar pustulosis (PPP) IP Route […]
Skin Barrier Dysfunction: Atopic Dermatitis and Beyond
Don't miss this opportunity to join us for an informative session on skin barrier dysfunction where you will learn about: The disorder and its role in atopic dermatitis The impact of immune dysregulations and microbiome abnormalities on inherent skin barrier anomalies Methods to study skin barrier integrity in clinical trials Questions? Contact us Newsletter […]
How to Write First-Rate Protocols for an Atopic Dermatitis Study - Focus: CLINICAL ASSESSMENTS AND ENDPOINTS
In recent years, therapeutics for dermatologic conditions have become a subspecialty of growing interest in the Clinical Research Organisation (CRO) industry, with clinical research in the area focused on a wide range of skin indications, such as acne vulgaris, psoriasis, and atopic dermatitis. What is atopic dermatitis? Atopic dermatitis (AD), also known as atopic eczema, […]
How to Write First-Rate Protocols for an Atopic Dermatitis Study - Focus: TREATMENT DURATION AND KEY ELIGIBILITY CRITERIA
In recent years, therapeutics for dermatologic conditions have become a subspecialty of growing interest in the Clinical Research Organisation (CRO) industry, with clinical research in the area focused on a wide range of skin indications, such as acne vulgaris, psoriasis, and atopic dermatitis. What is atopic dermatitis? Atopic dermatitis (AD), also known as atopic eczema, […]
How to Write First-Rate Protocols for an Atopic Dermatitis Study - Focus: STUDY DESIGN
n recent years, dermatologic therapeutics has become a subspecialty of growing interest in the CRO industry, with clinical research in the area focused on a wide range of skin indications such as acne vulgaris, psoriasis, and atopic dermatitis.
The Art of Protocol Writing in Dermatology
Watch this exciting and informative webinar on how to write the best protocols in dermatology. You will learn about: protocol development and associated tools; protocol considerations for key dermatology indications; clinical assessments, eligibility criteria, study design and more! Questions? Contact us Newsletter Get notified to have the latest trends and be at the […]
How to Handle Missing Data in Dermatology Trials
Watch this unique webinar to learn more about how to handle missing data in dermatology trials. You will learn more about: How missing data arises in dermatology studies Which statistical methods to choose to deal with missing data Which methods may be preferred by the Regulatory Bodies Questions? Contact us Newsletter Get notified to […]
