Use of an electronic data capture platform (EDC) for conducting screening studies

The bidder may be excluded if it, or a member of its administrative, management or supervisory body or an authorised representative, has a relevant final conviction within the previous five years or remains subject to an exclusion period for participation in a criminal organisation, corruption, fraud, terrorist offences, money laundering or terrorist financing, child labour or human trafficking. The stated grounds also include enabling the unlawful employment of a foreign national, and convictions for tax offences. Other grounds include unpaid taxes or social security contributions; breaches of environmental, social or labour-law obligations; bankruptcy, insolvency, liquidation, an analogous legal situation, an arrangement with creditors, assets administered by a liquidator or court, or suspended business activity; serious professional misconduct; agreements with other businesses intended to distort competition; an unmanageable conflict of interest; involvement in preparing the procurement that creates an unavoidable competitive advantage; and significant or persistent breaches of earlier public contracts resulting in early termination, damages, price reduction or penalties. Exclusion may also apply where the bidder has provided false or misleading information, withheld required information, failed to submit requested supporting documents, improperly sought confidential information or tried to influence the contracting authority’s decisions. A contract must not be awarded where doing so would breach an international or Estonian government sanction. If an exclusion ground applies, the bidder may provide evidence of measures taken to restore its reliability where the law or procurement documents allow this.

The bidder must have successfully completed at least one contract during the 36 months preceding the procurement for the right to use and support a software solution for healthcare, clinical studies or health data management. The bidder must provide information about the contract, including its value, date, duration and the other party. The bidder must appoint a project manager with at least three years’ experience managing software implementation or information-system deployment projects. A CV must be provided showing relevant projects, the person’s role and the project periods. The hosting environment for the proposed solution must have an information security management system meeting ISO 27001 or an equivalent standard. The bidder must provide a valid ISO/IEC 27001 certificate or other evidence demonstrating equivalent compliance. The bidder must confirm that the offer complies with the procurement documents and explain any claimed equivalence, supported by evidence. A technically compliant offer must be submitted using Annex 1 in Word format. The price must be submitted in the structure specified in the procurement documents, including Annex 2 in Excel format and the total price excluding VAT in euros in the procurement register’s price form; the stated amounts must be final, with no additional charges. The bidder must also submit the participation declaration using Annex 5, Form II. Joint bidders must appoint an authorised representative and include the power of attorney with their joint offer. The bidder must identify any trade secrets in the offer and explain their designation; the price and specified evaluation-related figures may not be designated as trade secrets. The notice does not specify the award-scoring method. The bidder must confirm that it will not involve, for more than 10% of the contract value, subcontractors or suppliers that are Russian nationals, residents or entities established in Russia; entities more than 50% directly or indirectly owned by such persons or entities; or persons or entities acting on their behalf or under their instructions. The bidder must also confirm that the goods offered are not subject to international sanctions and do not originate from sanctioned regions.