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Advanced therapy medicinal products (ATMP) are medicinal products involving cells, gene therapy or tissue engineering. They are used in many different indications, such as immune diseases, Parkinson’s and Alzheimer’s Disease, regenerative medicine (e.g., cartilage defects, wound healing), and cancer immunotherapy. As they are of biological / biotechnology origin, they require special legislation when it comes to market authorization. Therefore, this product class, which covers various new therapeutic strategies, requires special knowledge and experience.
Outline of a clinical trial covering the testing of ATMP in a joint:
The goal of this phase III clinical study was to demonstrate the efficacy of an ATMP in the treatment of cartilage defects in a joint. The efficacy was evaluated by patients’ subjective assessments and physicians’ evaluations of the functional efficacy of the product. The cartilage regenerative effects as well as the safety profile were additionally assessed.
With our structured and supportive approach, our excellent communication skills with investigational sites aided by our acquired experience in trials with ATMP, SCOPE was able to maintain the initial proposed timelines despite many unforeseen challenges.
In addition to general project management and clinical monitoring activities, we provide the following operations in the trial: budget planning and budget management, regulatory affairs, data management, EDC programming, safety management, pharmacovigilance, medical monitoring activities, statistical programming and analysis.
Due to regulatory timelines, only 10 sites were able to recruit during the first six months. Additionally, one country was unable to participate due to regulatory changes during the approval process. SCOPE had to replace seven sites during the recruitment phase of the trial. SCOPE’s success in replacing these sites was due in large part to the strong cooperation with sites of our investigator-network in already active countries. Additionally, a new country with three sites was added. The basis for this decision was founded in strategic knowledge of regulatory requirements for the country and the submission process. Another hurdle successfully handled was the unforeseen protocol update after the initial submission / approval. The initial recruitment goal was successfully met in the first half of the trial recruitment period. This was obtained despite regulatory delays that resulted in only 50% of the sites being active for the first half of the trial.
Despite the many hurdles and difficulties during the study planning and submission, all timelines were kept and all subjects were successfully recruited within the projected timelines. The challenge of the long-term follow-up and close cooperation with the sites is part of our current service.
SCOPE has experience in conducting clinical studies dealing with ATMPs and can therefore provide the specific knowledge necessary for navigating such a study.
General challenges for studies dealing with ATMPs
Our experiences / recommendations
e.g. Arthritis-related Pain, Bladder Pain Syndrome, Cancer Pain, Chronic Pain, Headache / Migraine, Lower Back Pain, Neuropathic Pain (diabetic, postherpetic), Postoperative Pain Management, Rheumatic Pain, Acute Postoperative / Procedural Pain
e.g. ART (IVF, ICSI), Contraception, Endometriosis, Fibromyalgia Syndrome (FMS), Obstetrics, Oncology, Pain Management, PCOS, Polymyalgia Rheumatica, Postmenopausal Complaints, Preterm labor, Rheumatoid Arthritis, Vaginitis, Vulvar and Vaginal Atrophy, Vulvovaginal Candidiasis
e.g. Asthma (mild, moderate, severe, paediatric), Asthma / COPD Overlap Syndrome (ACOS), Chronic Obstructive Pulmonary Disease (COPD), Community-Acquired Pneumonia (CAP), Respiratory VirusInfection (including paediatric)
e.g. Alzheimer’s Disease, Bipolar Disorder, Depression, Epilepsy (including paediatric), Mania, Multiple Sclerosis, Narcolepsy, Parkinson’s Disease, Sensorineural Disorder
e.g. Community-acquired pneumonia (CAP), COVID-19, GI and Intra-Abdominal Infections, Immune-Modulator to prevent SARS-CoV Complication, Respiratory Virus Infections (including paediatric)
e.g. Cell and Gene Therapies, Early-Phase Clinical Development of ATMPs, Immunotherapy, Personalized Therapies, Regenerative Medicine
We support projects focusing on conditions such as hypertension, myocardial infarction, and pulmonary arterial hypertension – all high-impact topics in cardiovascular care and research.
Our experience spans across immune-related areas like allergies and vaccinations – key therapeutic fields with growing relevance.
We help communicate complex topics in metabolic disorders, including type 1 diabetes, where patient education and clarity are crucial.
From Non-Hodgkin lymphoma to various solid tumors – such as bladder, breast, colorectal, or prostate cancer – we bring clarity to oncology and hematology communication.
We develop content for dental indications such as periodontitis, caries prevention, oral mucositis, and temporomandibular disorders – always with precision and sensitivity.
We work on indications like alopecia areata, hypertrophic scars, and psoriasis – conditions that often impact both physical and emotional wellbeing.
Our projects cover topics such as diabetes, hormonal imbalances, and metabolic disorders – essential areas in endocrinology.
From Crohn’s disease and ulcerative colitis to irritable bowel syndrome and reflux – we translate complex GI conditions into clear communication.
We support education and awareness campaigns on hepatitis B and C, liver fibrosis, non-alcoholic fatty liver disease (NAFLD), and cirrhosis – all major topics in liver health.
Conditions like rheumatoid arthritis and polymyalgia rheumatica require nuanced and evidence-based communication – a strength we bring to every campaign.
Whether it’s conjunctivitis or retinopathy – we create accessible content for eye disorders aimed at both professionals and patients.
Rare diseases like idiopathic sudden sensorineural hearing loss demand tailored, precise messaging – we’re here to deliver just that.
We support communication around orthopedic topics such as cartilage defects and osteoarthritis – with a focus on clarity and empathy.
From sudden hearing loss and rhinitis to rare conditions like Schwannomas – we bring ENT topics to life with targeted messaging.
We cover a range of urological topics – from bladder and prostate cancer to bladder pain syndrome and kidney cancer – always with scientific accuracy and approachability.
Our work includes vaccine communication for Hepatitis B, influenza, rabies, and tuberculosis – complex topics made clear and compliant.
