Initiation visit for new trial in Inlita:
First in dermatology,
First with medical device,
First time first trial in human,
First time for new sponsor in Lithuania.
B2B approach was used for establishing fourth Clinical Trial Site. Full service SMO agreement signed with JSC Baltic Medics. Operations will be conducted in therapeutic areas covered by JSC Baltic Medics license.
Inlita successfully participated in tender for services in incubator of BIO technologies in Santara clinics. Contract signed on 8thAugust, 2018.
Protocol approved by EC and CA for conducting trial for 2 Inlita sites on 8th March, 2018.
License for medical practice received on 19th September, 2017. New site is in Panevezys.
First permission to conduct phase II trial issued by State Medicines Control Agency on 14 Th September, 2017.
B2B (Shared Services) approach was used for establishing third Clinical Trial Site. We are sharing medical offices and equipment with JSC Kniaudiskių seimos klinika. Site will be in Panevezys.
B2B (Shared Services) approach was used for establishing agreement with Swiss biotechnology company Genoma. We are sharing services and medical offices according Inlita agreement with Center for Innovative Medicine of the National Science Research Institute.
Our partners site passed sponsor audit. No critical, no major findings.
Inspections by State Labour Inspectorate and National Health centre conducted. Recommendations implemented.
First Close-out Visit conducted on 6 Th April, 2017.
First protocol for local observational study, written by Inlita, approved by EC on 13th December, 2016.
First digital patient card created on September.
First GCP training conducted on 19th July, 2016. 8 investigators participated.
First patient successfully enrolled on 25Th of May – two weeks after SIV.
Inlita as a business enterprise has signed a cooperation agreement with academic Institution – The Lithuanian University of Health Sciences. Aim of this cooperation is to develop competencies in biomedical trials and creation of innovations.
First 2 SIVs conducted synchronically in Inlita Lazdynu site and our partners site Northway Clinic on 11Th of May (sponsors Novartis and Biomapas).
Inlita director Linas Liekis M.D. participated with presentation in a Conference “Santara Valley – opportunities for science, studies and business” organized by Ministry of Education and Science, Ministry of Economy and MITA on 29Th of April.
Second license for medical practice (Santaros clinical trial site) received on 11Th of April.
CA accepted GCP trainings program for investigators on 8Th Ferbruary.
First protocol approved by EC and CA for conducting trial approved on 30th December, 2015.
B2S approach: Inlita as a business enterprise has signed a cooperation agreement with scientific organization Center of Innovative Medicine of the National Science Research Institute. The provision of services is carried out in accordance with the open access management regulation of the Center. This cooperation provides an opportunity to use the services and facilities of the Center, modern biomedical research equipment and to work in joint projects with researchers of the Institute. Clinical Research Center is strategically located in Santariškės, Santara Valley (the integrated science, education and business center). Besides, there are open access laboratories, the largest of hospital of Vilnius University, Santariškės Clinics and other biomedical companies in the neighborhood. The aim is to create a clinical research center for conducting researches in many therapeutic areas.
First license for medical practice received on 27th October, 2015.
B2B approach was used for establishing first Inlita Clinical Trials Site. We are “sharing doctor office” with local laboratory “Rezus.lt”. Site is located in the same building as Vilnius University Hospital (RVUL).
First feasibility questionnaire received on 10th April, 2015. 5 Inlita sites involved.
First preliminary agreement with CRO – UAB “Parexel International” confirmed on 31st March, 2015
First agreement with medical institution – UAB “SK Impeks Medicinos diagnostikos centras” signed on 10th February, 2015
“Inlita”, UAB registration in Center of Registers of Lithuanian Republic confirmed on 7th January, 2015.
Company name registered in Vilnius on 29th December, 2014.